An observational study in Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension and Scleroderma Associated Pulmonary Arterial Hypertension, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged Up to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Vanderbilt University Medical Center · Observational
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Among 311 studies in Pulmonary Arterial Hypertension with a site in United States — 37 open to participants now, 55 under way, 12 of them phase 3. Pulmonary Arterial Hypertension · United States.
Among the 311 studies in Pulmonary Arterial Hypertension with a site in United States, this one is the 12th largest by planned enrollment of the 59 observational ones that give a count, is one of 14 that started in 2012, is one of 59 observational ones, reaches primary completion later than 54 of the 54 other live ones, and was the 125th registered.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
Browse Pulmonary Arterial Hypertension studies →37 of the 311 studies in Pulmonary Arterial Hypertension with a site in United States are open now. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 18+
National Heart, Lung, and Blood Institute (NHLBI) · Sites in United States
Ages 18–100
Liquidia Technologies, Inc. · Sites in United States
Ages 18–80
35Pharma Inc., a GSK company · Sites in United States, Spain, United Kingdom
Ages 18+
Insmed Incorporated · Sites in United States, Argentina, Australia and 5 more countries
Ages 18–75
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 90 Pulmonary Arterial Hypertension studies recruiting now, 51 (57%) set no upper age limit and 24 (27%) stop at 75 or younger; 18 take children under 18; 11 take healthy volunteers.
This study: Up to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
311 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 39 · Phase 2 94 · Phase 3 73 · Phase 4 32
First in 2002; this study’s year is marked. 14 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,899 is above the median of 104 across 181 observational studies indexed under Pulmonary Arterial Hypertension.
Median enrollment 40 across the 252 interventional studies, 67 across the 59 observational. Of the 235 that completed or were terminated, 133 (57%) have results posted.
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186 of 311 have an industry lead sponsor. The 10 most frequent:
Vanderbilt University Medical Center is the lead sponsor of 835 studies on the registry; 155 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 92 (73%) have results posted.
Vanderbilt University Medical Center has 9 studies filed under Pulmonary Arterial Hypertension — fewer than ten, so there is no comparison to draw.
18 of the studies in Pulmonary Arterial Hypertension with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT06274801Phase 3Gossamer Bio USA, Inc.Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) | 2026-12 |
| NCT05649748Phase 3Insmed IncorporatedAn Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH) | 2026-12-31 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07312227Massachusetts General HospitalA Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia | 2026-12 |
Add all 18 to your calendar (.ics) → With an account.
Among the 311 studies in Pulmonary Arterial Hypertension with a site in United States, from their registry updates:
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Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which underlie PAH will improve pulmonary vascular function and consequences of the disease.
Project 1: This project will work to understand why women are affected by pulmonary arterial hypertension (PAH) so much more often than men. This observation is true in heritable, idiopathic and associated forms of PAH. While males and females have some similar hormone levels, certain hormones exist at higher levels in each gender. For example, estrogen levels are much higher in females, and thus seemed the most sensible place to start looking for differences that may be affecting disease. In a small, early study of our heritable patients, we found differences in how patients break down estrogens as compared to healthy control subjects. Now, we want to confirm that what we found is true in a much larger group of patients that includes idiopathic and associated forms of PAH. We will also look to see if testosterone and other androgenic hormones are somehow protective for males. If the observation holds true in the larger group of patients, then we may try to "fix" the hormone imbalance in a mouse model of PAH with a drug therapy, and see if it helps improve the mouse pulmonary hypertension without bad side effects to the animals. If the animal drug studies work, then we may be able to try this drug in patients to see if it will work as a human treatment.
Project 2: Despite major advances in understanding PAH in recent decades, safe, effective and tolerable therapies remain elusive. The metabolic syndrome (central obesity, insulin resistance, high blood pressure and hyperlipidemia-fats in the blood) has been implicated in PAH. Treating the downstream consequences of insulin resistance in the pulmonary vasculature is a new approach to effective intervention against this highly mortal disease. This project will study the role of insulin resistance in pulmonary arterial hypertension and determine if therapies to treat insulin resistance will improve pulmonary arterial hypertension.
Project 3: In Project 3, we are working on the theory that PAH can be treated by fixing cell-cell junctions in blood vessels with a drug called recombinant ACE2(angiotensin converting enzyme 2). This is the only approach so far that has worked to reverse disease in mouse models of heritable PAH, but we need to better understand how it is working and make sure it has long term safety in animal models before starting human trials, hopefully within a few years. Definition: Cell-cell junctions-all of our organs and body structures are made from cells. Normally, these cells (think of a balloon filled with water) line up right next to each other so that the cell membranes touch each other. Materials can flow from one cell to the next. In PAH patients it is believed that the cells in the linings of the small arteries are not able to line up together as they should.
Cohort 1 subjects will be recruited from our adult and pediatric pulmonary vascular disease clinics. Cohort 2-healthy controls will be recruited form patients families and the general public in middle Tennesssee.
Inclusion Criteria:
Project 1
Inclusion:
Exclusion:
Project 2
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Exclusion:
Project 3
Inclusion:
Exclusion:
Age less than 7 or greater than 90
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with WHO Group 1 PAH
Subjects who have been evaluated for heart and lung disease and found to be healthy
Ratio of sex hormone metabolites
The primary outcome measure is the ratio of 2-hydroxyestrogens to 16-hydroxyestrogens among patients compared to both controls and at risk but well subjects.
Time frame: 5 years
Evaluation of insulin resistance in pulmonary arterial hypertension patients/Clinical trial of Metformin in Pulmonary Arterial Hypertension
We will assess various measures of insulin resistance among patients, compared to healthy control subjects as well as at risk but well subjects. The primary measure will be assessed using the glucose clamp technique to quantify insulin secretion and resistance.
Time frame: 5 years
Mechanism, safety, and efficacy of ACE-2 (Angiotensin Converting Enzyme 2) in the treatment of PAH.
We will assess the safety and efficacy of ACE-2 for the treatment of established PAH. The primary objective of the study is to determine safety of rhACE2 when administered as a single dose or multiple doses intravenously to subjects with PAH receiving background PAH-specific therapy.
Time frame: 5 years
Clinical Trial of Metformin in Pulmonary Arterial Hypertension
Specific Aim 1. To test the hypothesis that metformin will ameliorate oxidant stress in pulmonary arterial hypertension Primary safety endpoint: absence of lactic acidosis, withdrawal from the study if attributed to metformin Primary efficacy endpoint: change in urinary and plasma oxidant stress measures (F2 isoprostanes and metabolites, isofurans, and nitrotyrosine) Specific Aim 2. To test the hypothesis that metformin will decrease myocardial lipid content, increase oxidative metabolism and decrease glucose uptake. Primary Endpoints: change in myocardial percent triglycerides (%TGs), kmono/RPP of C11 acetate, and uptake of FDG before and after metformin.
Time frame: 3 years
Mechanism, safety, and efficacy of ACE-2 in the treatment of PAH.
The secondary objective of the study is to evaluate changes in biomarkers of disease (BNP, AngII/Ang (1-7, serum soluble IDH, serum NO, cardiac troponin I, SOD2 activity, urine isoprostanes and isofuranes) in subjects with PAH receiving rhACE2. We will also evaluate changes in pulmonary and systemic hemodynamics and echocardiographic markers of right heart function in patients receiving rhACE2.
Time frame: 5-year
Clinical Trial of Metformin in Pulmonary Arterial Hypertension
Specific Aim 1. To test the hypothesis that metformin will ameliorate oxidant stress in pulmonary arterial hypertension Secondary Endpoints: lung cellular proliferation as measured by FDG avidity, change in the markers of insulin resistance and sensitivity, BMPR2 expression in peripheral blood mononuclear cells, and change in glucose and lipid metabolites. Specific Aim 2. To test the hypothesis that metformin will decrease myocardial lipid content, increase oxidative metabolism and decrease glucose uptake. Secondary Endpoints: change in RVEF, RV mass index, insulin resistance and sensitivity indices, glucose and lipid metabolites, and six-minute walk distance (6MWD)
Time frame: 3 years
The record gives a start of Sep 2012, a primary completion of Jul 2032 and a completion of Jul 2032. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Pulmonary Arterial Hypertension →
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