In Situ Measurement of Anti-Apoptotic Phenotype in the Pulmonary Arterial Endothelium and Its Association with Pre-Capillary Disease in Pulmonary Hypertension
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-008242
Sponsor Protocol Number: 18-008242
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Written informed consent obtained from subject
- Male or female, at least 18 years of age
- Diagnosis or suspected IPAH, heritable PAH (WHO group 1 PH), or PH-HFpEF (WHO group II PH). Both naïve and prior treated patients are included.
- The diagnosis of group I (IPAH and heritable) and group II PH will conform with the present guidelines classification and be confirmed by each site investigator.
- Subject must have mPAP of ≥25 mmHg during the clinically indicated right heart catheterization
Exclusion Criteria:
- Subjects with other forms of WHO group I PH (i.e. secondary to connective tissue disease or congenital heart disease)
- Subjects with WHO group 3 PH (TLC< 70% or FEV1 < 55%)
- Subjects with WHO group 4 or 5 PH
- Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- Subjects, in the Investigator’s opinion, unable to tolerate a right heart catheterization.
- Subjects on chronic renal dialysis
- Left ventricular ejection fraction less 50% on most recent echocardiogram
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Robert Frantz, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available