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A Study to Assess Frailty and Its Impact on Patients with Pulmonary Hypertension
Rochester, MN
The purpose of this study is to evaluate the prevalence and effect of frailty in patients referred to pulmonary hypertension (PH) clinic at our institution.
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Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
Rochester, MN
The purpose of this study is to evaluate the effects of RT234 on exercise parameters assessed by a specialized exercise test (Cardiopulmonary Exercise Test or CPET) in patients with pulmonary arterial hypertension (PAH).
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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
Jacksonville, FL
The purpose of this study is to assess the effect of Treprostinil Palmitil Inhalation Powder (TPIP) compared with placebo on pulmonary vascular resistance (PVR).
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A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
Rochester, MN
The purpose of this study is to see if patients with Pulmonary Arterial Hypertension related to Interstitial Lung Disease (ILD-PAH) will have impaired cardiac output reserve and leg blood flow during exercise, and inhlaed treprostinil will acutely increase exertional leg blood flow and cardiac output with preserved skeletal muscle O2 uptake efficiency, and to see a baseline hemodynamic improvement in exertional cardiac output with inhaled treprostinil will predict subsequent NYHA class improvement at 3 months with chronic inhaled treprostinil therapy.
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A Study to Assess the Aria CV Pulmonary Hypertension System to Treat Pulmonary Arterial Hypertension
Rochester, MN
The purpose of this study is to assess the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary arterial hypertension.
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In Situ Measurement of Anti-Apoptotic Phenotype in the Pulmonary Arterial Endothelium and Its Association with Pre-Capillary Disease in Pulmonary Hypertension
Rochester, MN
The purpose of this study is to collect pulmonary arterial endothelial cells from the balloon tips of pulmonary artery catheters (PAC) during right heart catheterization (RHC) and to measure bcl-2 protein expression in these cells in order to index this measurement to a composite hemodynamic and clinical indicators of precapillary vascular disease in pulmonary hypertension.
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A Study Evaluating the Long-Term Effectiveness and Safety of Ralinepag in Subjects with PAH Via an Open-Label Extension
Jacksonville, FL
The purpose of this study is to evaluate the long-term safety and tolerability of ralinepag (APD811) in subjects who have participated in a preceding Phase 2 or Phase 3 study of ralinepag. MCF will not participate in the PK Substudy.
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An Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil
Rochester, MN
The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).
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A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
Jacksonville, FL
The purpose of this study is to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.
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United States Pulmonary Hypertension Scientific Registry (USPHSR)
Rochester, MN
The purpose of the United States Pulmonary Hypertension Scientific Registry (USPHSR) will be to promote a greater understanding of PAH in an era of genetic discoveries, the study of the physical make up of individual people, and new treatments through education and collaborative assessment of information among pulmonary hypertension (PH) centers throughout the U.S. The development of a national USPHSR Registry will be an important element for advancement of the understanding of PAH and improvement of the care of patients who suffer from this life threatening disorder.
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A Study to Evaluate Whether or Not Selexipag is Effective and Safe in Patients with Chronic Thromboembolic Pulmonary Hypertension when the Disease is Inoperable or Persistent/Recurrent After Surgery
Jacksonville, FL
The primary objective of this study is to evaluate the effect of selexipag on pulmonary vascular resistance (PVR) versus placebo in subjects with inoperable CTEPH (i.e., technically non-operable) and persistent/recurrent CTEPH after surgical (pulmonary endarterectomy [PEA]) and/or interventional (balloon pulmonary angioplasty [BPA] treatment at Week 20.
The secondary objectives are to evaluate the effects of selexipag versus placebo on exercise capacity, rate of death or hospitalizations related to Pulmonary Hypertension (PH) worsening, time to clinical worsening, WHO functional class (FC), patient reported outcomes, dyspnea, and N-terminal pro b-type natriuretic peptide (NT-proBNP).
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National Biological Sample and Data Repository for Pulmonary Arterial Hypertension
Rochester, MN
The purpose of this study is to establish a collection, termed biorepository or biobank, of samples as well as both clinical and genetic data from patients with pulmonary arterial hypertension.
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An Extension Study to QTI571A2301 to Evaluate the Long-Term Safety, Tolerability and Effectiveness of Imatinib in Severe Pulmonary Arterial Hypertension
Rochester, MN
The purpose of this extension study is to provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.
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Role of the Gut Microbiome in Pulmonary Hypertension
Jacksonville, FL
Pulmonary hypertension (PH) is a progressive, symptomatic, and ultimately fatal disorder for which there are no effective therapies. Resident gut microbiota are now recognized as potent modifiers of the host immune responses in various pathologies. Evidence from animal studies suggest that the microbial composition is altered in lung diseases such as asthma, chronic obstructive pulmonary disorders (COPD) and cystic fibrosis. Our goal in this study will be to determine and compare the gut microbial composition between healthy individuals and pulmonary hypertensive patients.
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A Study Comparing the Effectiveness and Safety of Combining Three versus Two Oral Treatments for the Initial Therapy of Patients who have Newly Diagnosed Hypertension of the Pulmonary Artery
Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of three (macitentan, tadalafil, and selexipag) versus two (macitentan and tadalafil) oral treatments for patients who have newly diagnosed and untreated hypertension of the pulmonary artery.
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Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Rochester, MN
STUDY OBJECTIVES Primary objective(s) To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.
Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation.
To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD implantation.
Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to placebo on right ventricular function ...
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A Study of Financial Burden of Medical Therapy in Patients with Pulmonary Arterial Hypertension (PAH)
Jacksonville, FL
The purpose of this study is to:
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To assess out of pocket expenditures of patients on medical therapy for Group 1 PAH, its impact on medication affordability and whether that adversely affected treatment regimens.
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To analyze potential effects associated with the financial burden of PAH medical therapy.
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The secondary outcome is to assess the impact of pulmonary arterial hypertension on healthy lifestyle of the patients.
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A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (STELLAR)
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of Sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with Pulmonary Arterial Hypertension (PAH).
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A Long-term Follow-up Study of Sotatercept for PAH Treatment
Jacksonville, FL
The purpose of this study is to assess the long-term safety, tolerability, and effectiveness of sotatercept in Pulmonary Arterial Hypertension (PAH).
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A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)
Rochester, MN; Jacksonville, FL
The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood and on exhaled volatile organic compounds (VOC) in the breath associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, ...
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A Study with to Assess the Effectiveness and Safety of Selexipag as Standard-of-Care Add-on in Subjects with Inoperable or Persistent/Recurrent After-surgical Treatment CTEPH
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of Selexipag in subjects with inoperable or persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
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A Study of Functional Class Self Report in Pulmonary Hypertension
Rochester, MN
The purpose of this study is to evaluate the Pulmonary Hypertension Functional Class Self Report (PHFC-SR) ratings for a sample of subjects with pulmonary hypertension (PH).
A secondary purpose is to explore the concordance between the patient-reported PH-FC-SR and clinician-assessed World Health Organization Functional Classification (WHO-FC) measure in a sample of subjects with PH, and to assess the construct validity between the patient-reported PH-FC-SR and a patient-reported disease-specific measure and a general health-related quality of life (HRQOL) measure.
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Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension
Rochester, MN
The purpose of this study is to characterize the clinical and hemodynamic response of PAH therapy in patients with atypical PAH and risk factors for left heart disease.
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A Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).
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A Study to Determine if Early Changes of Pulmonary Artery Hypertension can be Seen by Adding Exercise During Cardiac Magnetic Resonance Imaging (MRI)
Jacksonville, FL
The purpose of this study is to evaluate the diagnostic benefit of adding exercise to cardiac Magnetic Resonance Imaging to help show early changes that may assist in the earlier diagnosis of Pulmonary Artery Hypertension.
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A Study to Evaluate GB002 in Adults with Pulmonary Arterial Hypertension (PAH)
Jacksonville, FL; Rochester, MN
The primary objective of this trial is to determine the effect of GB002 on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III.
The secondary objective is to determine the effect of GB002 on improving exercise capacity in this population.
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A Study of Alveolar-Capillary Recruitment as a Screening and Tracking Tool for Patients with Pulmonary Arterial Hypertension
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if non-invasive measurement of blood flow to the lungs and the movement of gas from the lungs to the blood stream at rest and in response to low to moderate intensity exercise can be used as an assessment tool to allow for earlier detection and monitoring of individuals with pulmonary-arterial hypertension, and the response to drug treatments.
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A Study of Macitentan in Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effect of macitentan 10 mg on pulmonary vascular resistance as compared to placebo in subjects with pulmonary hypertension after left ventricular assist device (LVAD) implantation
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Are Gene Variants that are Associated with Acute Vasoreactivity in Idiopathic Pulmonary Arterial Hypertension (IPAH) also Present in a Patient with Associated PAH due to Scleroderma
Jacksonville, FL
The purpose of this study is to assess known gene variants in a patient with associated pulmonary arterial hypertension (PAH) due to scleroderma who is clinically vasoreactive to compare to published variants that are predictive of acute vasoreactivity in idiopathic PAH.
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Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil
Rochester, MN
The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.
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A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants
Rochester, MN
The purpose of this study is to describe the time to all-cause death and time to death due to pulmonary arterial hypertension (PAH) or first hospitalization due to PAH in the overall study population and within each cohort.
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A Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension Patients
Jacksonville, FL
The primary purpose of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.
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A Phase 3 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of L606 in Subjects With PAH
Jacksonville, FL
The purpose of this study is to demonstrate the safety and tolerability of repeated doses of L606 in patients with PAH switching from a stable Tyvaso dose. The current Phase 3 study will help determine the short-term and long-term safety and tolerability of L606 in this patient population. The study will also evaluate the steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise ability (6-minute walk distance [6MWD] and Borg Dyspnea Score), quality of life (QoL), and treatment satisfaction with L606 in patients with PAH.
Part 1 of the study is short-term (2-week) evaluation of L606 in patients with PAH. Part 2 of the study will ...
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A Study of Ubenimex in Patients with Pulmonary Arterial Hypertension
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of ubenimex in patients who have pulmonary arterial hypertension, to improve exercise capacity and delay clinical worsening.
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A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension
Rochester, MN
The purpose of this study is to evaluate the effect of sotatercept (ACE-011) in adults with Pulmonary Arterial Hypertension. Each eligible participant will receive standard of care (SOC) plus sotatercept (ACE-011) for a 24 week treatment period followed by a 16 week follow up period.
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A Registry for the Scientific Study of Pulmonary Hypertension in the United States
Jacksonville, FL
The purpose of this study is to identify, characterize, and study a group of patients who have pulmonary hypertension, newly diagnosed in the current treatment era, when investigators can use the contributions of genomics and clinical imaging tests to further understand the disease. This registry should advance knowledge in the field both from a molecular (genomic and proteomic) and from a clinical phenotype standpoint.
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A Study to Evaluate the Safety and Tolerability of TreT in Subjects with PAH Currently Using Tyvaso
Jacksonville, FL
The purpose of this study is to evaluate pulmonary arterial hypertension (PAH) subjects on a stable regimen of Tyvaso after switching to a corresponding dose of TreT.
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International BPA Registry
Rochester, MN
The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).
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A Biorepository to Study Portopulmonary Hypertension
Rochester, MN
We propose to develop a biorepository of plasma samples from patients with suspected and confirmed portopulmonary hypertension to improve our understanding of this disease and its response to pulmonary arterial hypertension targeted therapy and liver transplantation.
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Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil
Jacksonville, FL
The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.
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A Study to Evaluate Effectiveness of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
Jacksonville, FL
The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with pulmonary arterial hypertension (PAH).
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A Study to Establish a Registry for the Pulmonary Hypertension Association
Jacksonville, FL
The objectives of this study are to measure and improve quality of care (including assessing differences in adherence to evidence-based guidelines and establishing benchmarks for health outcomes); determine the clinical effectiveness, comparative effectiveness, and cost effectiveness of treatment approaches; understand risk factors for outcomes and regional/center differences; and facilitate funded clinical trials of new therapies and collaboration with the PAH community at large, including providers, patients, and their caregivers.
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Pulmonary Hypertension Association Registry (PHAR)
Jacksonville, FL
The goals of the PHAR include 1) measuring and improving quality of care (including assessing differences in adherence to evidence-based guidelines and establishing benchmarks for health outcomes), 2) determining the clinical effectiveness, comparative effectiveness, and cost effectiveness of treatment approaches, 3) understanding risk factors for outcomes and regional/center differences, and 4) facilitating funded clinical trials of new therapies and collaboration with the PAH community at large, including providers, patients, and their caregivers.
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A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
Rochester, MN
This is a prospective, multicenter, open-label, randomized, controlled, parallel group, group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and pharmacokinetics (PK) of macitentan in children.
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Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Jacksonville, FL
The purpose of this extension study is to evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
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A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effect of Rodatristat Ethyl from baseline on pulmonary vascular resistance as measured at right heart catheterization.
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An Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan to Treat Patients with Pulmonary Arterial Hypertension
Scottsdale/Phoenix, AZ
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
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A Study to Identify the Molecular Basis of Pulmonary Vascular Disease and to Discover Biological Measurements of the Disease and Therapeutic Responses
Rochester, MN
The purpose of this study is to identify the molecular basis of various forms of heart and lung disease, particularly those that have varying degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular dysfunction.
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U.S. CTEPH Registry
Jacksonville, FL
The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of the Registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of patients with CTEPH through shared information, education, and collaborative investigation among pulmonary hypertension (PH) centers of excellence throughout the U.S.
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A Study to Evaluate the Long-Term Safety and Effectiveness of Ubenimex in Patients with Pulmonary Arterial Hypertension
Rochester, MN
The purpose of this study is to evaluate the long-term safety, tolerability, and effectiveness of ubenimex for the treatment of patients who have pulmonary arterial hypertension, to improve exercise capacity and delay clinical worsening.
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A Study to Evaluate the Effectiveness and Safety of Ralinepag To Improve Treatment Outcomes in Peripheral Arterial Hypertension (PAH) Patients
Scottsdale/Phoenix, AZ
To evaluate the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH
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A Study to Evaluate the Effectiveness and Safety of RalinEpag for Improving Treatment Outcomes in PAH Patients
Jacksonville, FL
The purpose of this study is to demonstrate the effect of ralinepag the time to first adjudicated clinical worsening event in subjects with pulmonary arterial hypertension (PAH).Clinical worsening event is defined as 1 of the following: death, nonelective hospital admission of <24 hours="" due="" to="" worsening="" pah="" or="" rhf,="" initiation="" of="" parenteral="" or="" inhaled="" therapy,="" disease="" progression,="" or="" unsatisfactory="" long="" term="" clinical="">24>
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A Study to Develop a Pulmonary Hypertension Association Registry (PHAR)
Rochester, MN
The primary purpose of this study is to measure and improve quality of care (including assessing differences in adherence to evidence-based guidelines and establishing benchmarks for health outcomes).
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Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial – Follow up Long Term Extension (IMPAHCT-FUL)
Jacksonville, FL
The purpose of this study is to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures (e.g., 6MWD, NT-proBNP, cardiac echo) will also be assessed.
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National Biological Sample and Data Repository for Pulmonary Arterial Hypertension
Jacksonville, FL
The specific purpose of this study is to establish a national biorepository of biological samples and genetic data of patients with the World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH). The function of this biorepository is to collect the samples from the patients, generate the proposed genetic data, and widely promote and distribute the samples/data to the scientific community. Investigators requesting samples will submit requests and proposed uses of the samples which will be reviewed by a committee comprised of investigators from several of the enrolling centers.
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Pulmonary Hypertension Association Registry
Rochester, MN
The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC with follow-up data collected at approximately 6-month intervals.
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A Study of an Implantable System for Remodulin Post Approval
Rochester, MN
The purposes of this study is to estimate the freedom from catheter-related complications through 5 years post-implant and to estimate the freedom from ISR pump failures through 5 years post- implant.
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GS-4997 in Adults With Pulmonary Arterial Hypertension
Rochester, MN
This study will compare the efficacy, safety, and tolerability of three doses of GS-4997 to placebo in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term GS-4997 treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with GS-4997 in the long-term treatment period.
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Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension
Rochester, MN
The aim of this study is to evaluate the effects of a home-based program with health coaching of dyspnea and exercieses in subjects with pulmonary arterial hypertension (PAH).
Pulmonary rehabiltation has been shown to be an effective treatment for patients with chronic obstructive pulmonary disease, however there is currently a paucity of evidence to extrapolate this informaiton with patients with pulmonary arterial hypertension (PAH). In addition, there are no options outside of center-based pulmonary rehabilitation which have been proposed as an effective treatment option for patients with PAH.
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A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)
Jacksonville, FL
The purpose of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.
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Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension
Rochester, MN
The primary purpose of this study is to determine the impact of two interventions against insulin resistance on the composite endpoint of 10% improvement in baseline six minute walk distance or improvement in WHO functional class.
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A Study to Form a Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)
Rochester, MN
The purpose of this study is to form a registry to follow patients with sarcoidosis associated pulmonary hypertension
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A Study to Evaluate the Safety and Effectiveness of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Jacksonville, FL
The primary purpose of this study is to demonstrate the safety and effectiveness of ozanimod compared to placebo on the maintenance of clinical remission and endoscopic response.
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Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients with Pulmonary Hypertension
Jacksonville, FL
The purposed of this study are to investigate whether structured exercise training improves cardiac and pulmonary haemodynamic function, exercise capacity, and short-term clinical outcomes in heart failure (HF) patients with Pulmonary Hypertension (PH), and to develop a multivariable exercise pulmonary gas exchange ‘score’ that accurately differentiates HF patients with pre- and post-capillary PH (CpcPH) from HF patients with isolated post-capillary PH (IpcPH).
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Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PHHFpEF)
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects.
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A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Effectiveness is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).
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A Study to Evaluate Heart Disease and Pulmonary Hypertension Voice Characteristics
Rochester, MN
The purpose of this study is to determine the association between patient voice signal characteristics and the presence and severity of pulmonary hypertension in patients referred for elective clinically indicated echocardiography for at Mayo Clinic MN.
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A Study of Levosimendan in Pulmonary Hypertension (PH) with Heart Failure (HF) and Preserved Left Ventricular Ejection Fraction (pEF) Patients
Rochester, MN
The purpose of this study is to evaluate for safety and effectiveness weekly, open-label doses of levosimendan over extended use in patients with pulmonary hypertension with heart failure and preserved left ventricular ejection fraction (PH-HFpEF).
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PORtopulmonary Hypertension Treatment wIth maCitentan ─ a randOmized Clinical Trial
Rochester, MN
24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.
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A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and efffectiveness of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy.
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A Study to Assess Quality of Life with the PAH SYMPACT Questionnaire in the Pulmonary Hypertension Clinic
Rochester, MN
The primary purpose of this study is to administer the PAH SYMPACT questionnaire in 200 consecutive eligible patients attending the Mayo Clinic pulmonary hypertension clinic. An additional patient satisfaction survey will be administered for patients that completed a palliative care consult.
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Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE
Jacksonville, FL; Rochester, MN
This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).
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Rivet PVS Therapy in Group 2C
Rochester, MN
The purpose of this study is to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.
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Pulmonary Hypertension and Chronic Kidney Disease
Rochester, MN
The aims of this study are to establish a registry and biorepository of patients with PH-CKD, and to identify clinical risk factors and biomarkers associated with PH-CKD and different hemodynamic phenotypes.
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Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial
Rochester, MN
The enormous and rapidly growing burden of Heart Failure with Preserved Ejection Fraction (HFpEF) has led to a need to understand the pathogenesis and treatment options for this morbid disease. Recent research from the investigator's group and others have shown that pulmonary hypertension (PH) is highly prevalent in HFpEF, and right ventricular (RV) dysfunction is present in both early and advanced stages of HFpEF.
These abnormalities in the RV and pulmonary vasculature are coupled with limitations in pulmonary vasodilation during exercise. There are no therapies directly targeted at the pulmonary vasculature that have been clearly shown to be effective ...
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Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)
Jacksonville, FL
This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects will take the initial dose of study drug at the study site on the day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.
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Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)
Jacksonville, FL
This is an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil becomes commercially available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.
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Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Jacksonville, FL
The purpose of this open-label study is to evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).
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Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure
Rochester, MN
This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.
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Pulmonary Vascular Complications of Liver Disease-2
Rochester, MN
The purpose of this study is to determine if certain genes, hormones, or other factors predict the risk of developing lung vessel disease in patients with liver disease and whether they determine outcome.
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SYMPHONY: A Study of Macitentan in Pulmonary Arterial Hypertension to Validate the PAH-SYMPACT
Scottsdale/Phoenix, AZ
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive macitentan, 10 mg, once daily.
The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument, to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT instrument to detect change. The secondary objective is to assess the safety of macitentan in ...
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A Study to Evaluate Cardiopulmonary Complications in Systemic Sclerosis
Rochester, MN
The purpose of this study is to assess whether our not the percentage of pulmonary related vascular structures (PRVS) determined by the quantitative CT (Q-CT) tool CALIPER is a novel measure that can be used for the early detection of pulmonary vascular remodeling in patients with SSc. pulmonary related vascular structures
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A Study to Evaluate Pulmonary Vascular Complications of Liver Disease 3 (PVCLD3)
Rochester, MN
The purpose of this study is toexamine whether increased sphingosine 1 phosphate : ceramide ratio and circulating bile acids are associated with HPS in patients with advanced liver disease.
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Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation
Rochester, MN
We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.
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Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Jacksonville, FL
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso® (treprostinil) Inhalation Solution versus other FDA approved therapies.
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An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
Jacksonville, FL; Rochester, MN
This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available ...
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Systolic Pressure Intervention Trial Factors Affecting Atherosclerosis Study
Jacksonville, FL
Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of ~ 9250 adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial will test the effects of low systolic blood pressure (SBP) goal of < 120 mm Hg versus the standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death. One of the pre-specified secondary outcome is the progression of kidney disease. In this ancillary named SPRINT - Factors affecting Atherosclerosis ...
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A Study of Tricuspid Regurgitation Absence in Pulmonary Hypertension
Jacksonville, FL
The purpose is to study the correlation of right ventricular strain by tissue Doppler and Tricuspid Annular Plane Systolic Excursion (TAPSE) in patients without a tricuspid regurgitation jet with the presence and severity of pulmonary artery hypertension diagnosed by right heart catheterization. The primary aim is to determine the correlation of other echocardiographic, laboratory and clinical findings in patients without a tricuspid regurgitation jet with the presence and severity of pulmonary artery hypertension diagnosed by right heart catheterization. As such, one goal is to potentially create a predictive score with adequate sensitivity to determine which patients without a tricuspid regurgitation ...
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A Study of the Effectiveness of Palliative Care Consultation for Patients with Advanced Lung Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the usefulness of palliative care consultations by a specialty physician and a pulmonologist for patients who have advanced lung disease.
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A Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
Jacksonville, FL
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).
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A Study of the Effect of Sildenafil for Improvement of Hepatic Fibrosis after the Fontan Heart Surgery
Rochester, MN
The purpose of this study is to determine if vasodilators for the lungs can decrease liver stiffness, shown by Magnetic resonance elastography (MRE). The study also aims to identify any clinical, laboratory, echocardiographic, imaging, and hemodynamic parameters that connect with improved outcomes of cardiac and liver status after starting the pulmonary vasodilators.
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Vascular Diseases Biorepository
Rochester, MN
The eventual goal of this study is to identify genetic and proteomic markers that may influence susceptibility to vascular diseases including peripheral arterial disease, pulmonary hypertension, carotid artery stenosis, arterial aneurysmal disease, fibromuscular dysplasia, congenital heart disease and other less common diseases that affect the blood vessels.
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A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting
Rochester, MN
The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.