Repurposing Valsartan May Protect Against Pulmonary Hypertension

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Washington

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Valsartan 40 mg
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator