RecruitingPhase 2NCT06053580

Repurposing Valsartan May Protect Against Pulmonary Hypertension

Sponsor

University of Washington

Enrollment

60 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria11

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