Status:
RECRUITING
Repurposing Valsartan May Protect Against Pulmonary Hypertension
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Arterial Hypertension
Right Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, single-center, randomized placebo controlled trial of valsartan (an angiotensin receptor blocker) in adults with pulmonary arterial hypertension. The study will evaluate the safety ...
Detailed Description
Pulmonary arterial hypertension (PAH) is one of many conditions that put stress and strain on the right side of the heart. This stress and strain can cause right heart failure. Although there are medi...
Eligibility Criteria
Inclusion
- Male or female, age 18 to 80
- WHO Group 1 Pulmonary Arterial Hypertension
- NYHA Functional Class II, III, or IV at screening (Appendix 2 for Functional Class Decision Aid)
- Right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥25 mmHg, occlusion pressure of ≤15 mmHg, and resistance ≥ 3 wood units
- Participants with a right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg and occlusion pressure of 15 - 20 mmHg will be considered for inclusion if the pulmonary vascular resistance ≥ 9 wood units and they are being treated with pulmonary arterial hypertension specific therapy
- Able to walk with/without a walking aid for a distance of at least 50 meters
Exclusion
- Pregnant or lactating
- Non-group 1 pulmonary hypertension or veno-occlusive disease
- History of interstitial lung disease, unless subject has collagen vascular disease and has pulmonary function testing conducted within 12 months demonstrating a total lung capacity or vital capacity of ≥ 60 %
- Has received or will receive an investigational drug, device, or study within 30 days or during the course of study
- ACE-inhibitor, ARB or ARNI use within 30 days of randomization.
- Left sided myocardial disease as evidenced by left ventricular ejection fraction \< 40%
- Any other clinically significant illness or abnormal laboratory values (measured during the Screening period) that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data
- Anticipated survival less than 1 year due to concomitant disease
- Allergy or angioedema with ACE-inhibitor use
- Potassium \>5mEq/L or sCr \>2mg/dL at screening
- SBP \<90mmHg at screening
Key Trial Info
Start Date :
February 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06053580
Start Date
February 28 2024
End Date
July 1 2027
Last Update
March 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Washington Medical Center
Seattle, Washington, United States, 98195