Robert P. Frantz, M.D.

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.

The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

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.

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).

The purpose of this study is to investigate the long-term safety, tolerability, and efficacy of orally inhaled seralutinib in subjects with Pulmonary Arterial Hypertension.

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 patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.

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).

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.

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.

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.

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.

24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.

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.

The purpose of this study is to provide ongoing support for pump refills, and replacement systems when needed, to the remaining 30 subjects in the DelIVery for PAH Study. This study will also provide monitoring and periodic reporting of safety of the Pulmonary Arterial Hypertension Implantable Vasodilator Therapy (“PIVoT”) investigational system.

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.

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. 

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).

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.

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.

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.

The purpose of this study is to retest participants at a minimum 6 month interval from initial evaluation using a core set of clinical and OMICS features. This will include survival, clinical staging, clinical group assignment, 6-minute walk, echocardiography, and blood for a broad collection of selected OMICS tests, to include proteomics and other variables found to be informative in the initial set.

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.

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.