Recruiting
Phase 2

Valsartan

Sponsor:

University of Washington

Code:

NCT06053580

Conditions

Pulmonary Arterial Hypertension

Right Heart Failure

Right Ventricular Dysfunction

Pulmonary Vascular Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Valsartan 40 mg

Placebo

Study Details

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 and clinical efficacy of a 24-week course of valsartan.

Conditions

Pulmonary Arterial Hypertension

Right Heart Failure

Right Ventricular Dysfunction

Pulmonary Vascular Disorder

Study ID

NCT06053580

Start date

Feb 28, 2024

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Valsartan

Valsartan 40mg capsule taken twice daily for 24 weeks.

placebo comparator: Placebo

Placebo capsule taken twice daily for 24 weeks.

Interventions

Valsartan 40 mg

Valsartan 40mg twice daily for 24 weeks.

Placebo

Placebo twice daily for 24 weeks.

Primary outcome measure

  • Six-minute walk distance [ Time Frame: 0 to 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Principal Investigator:

Peter J Leary, MD, PhD

More Information

Sponsor

University of Washington

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-04.