NCT06053580 · University of Washington
Repurposing Valsartan May Protect Against Pulmonary Hypertension
(REVAMP-PH)
What this study is about
This is a Phase 2, single-center, randomly assigned placebo controlled trial of valsartan (an angiotensin receptor blocker) in adults with pulmonary arterial hypertension. The study will evaluate the safety and clinical effectiveness of a 24-week course of valsartan.
View original scientific description
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 and clinical efficacy of a 24-week course of valsartan.
Interventions
DRUG
Valsartan 40 mg
Valsartan 40mg twice daily for 24 weeks.
DRUG
Placebo
Placebo twice daily for 24 weeks.
Primary outcome measures
Six-minute walk distance
Time frame: 0 to 24 weeks
To determine whether valsartan increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Seattle, Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations