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
Sponsors and collaborators
University of Washington
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator