Using valsartan to help treat pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-center, randomized placebo-controlled trial investigates the effects of valsartan, an angiotensin receptor blocker, on adults with pulmonary arterial hypertension (PAH). The study aims to evaluate the safety and clinical efficacy of a 24-week treatment course of valsartan, focusing on its potential to improve right heart function under stress. Participants will be monitored through standard clinic visits and echocardiograms, with some assessments potentially conducted remotely. The trial seeks to determine if valsartan can provide a new therapeutic approach for managing right heart failure associated with PAH.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, age 18 to 80
2. WHO Group 1 Pulmonary Arterial Hypertension
3. NYHA Functional Class II, III, or IV at screening (Appendix 2 for Functional Class Decision Aid)
4. 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
5. 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
6. Able to walk with/without a walking aid for a distance of at least 50 meters

Exclusion Criteria:

1. Pregnant or lactating
2. Non-group 1 pulmonary hypertension or veno-occlusive disease
3. 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 %
4. Has received or will receive an investigational drug, device, or study within 30 days or during the course of study
5. ACE-inhibitor, ARB or ARNI use within 30 days of randomization.
6. Left sided myocardial disease as evidenced by left ventricular ejection fraction \< 40%
7. 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
8. Anticipated survival less than 1 year due to concomitant disease
9. Allergy or angioedema with ACE-inhibitor use
10. Potassium \>5mEq/L or sCr \>2mg/dL at screening
11. SBP \<90mmHg at screening

Where it's running

• University of Washington Medical Center
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Peter Leary, MD, PhD — University of Washington
• Study coordinator: Laurie Hogl, RRT
• Email: lalnaser@uw.edu
• Phone: 206.543.8334

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.