Using valsartan to help treat pulmonary hypertension

Repurposing Valsartan May Protect Against Pulmonary Hypertension

This study is testing if the medication valsartan can help adults with pulmonary arterial hypertension feel better and improve their heart function.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06053580 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with WHO Group 1 pulmonary arterial hypertension and specific functional classifications.

Not a fit: Patients with non-group 1 pulmonary hypertension or those with a history of interstitial lung disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve heart function and quality of life for patients with pulmonary arterial hypertension.

How similar studies have performed: Preliminary results from other studies suggest potential benefits of valsartan for right heart function, but this specific approach is still being evaluated.

Eligibility criteria

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 this trial is running

Seattle, Washington

• 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

Conditions Pulmonary Arterial Hypertension; Right Heart Failure; Right Ventricular Dysfunction; Pulmonary Vascular Disorder