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.
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
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
Parallel
Valsartan 40 mg
DrugValsartan 40mg twice daily for 24 weeks.
Placebo
DrugPlacebo twice daily for 24 weeks.
Six-minute walk distance
To determine whether valsartan increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension.
Change in BNP
To determine whether valsartan reduces BNP at 24 weeks
Change in New York Heart Association (NYHA) functional class
To determine whether valsartan improves New York Heart Association (NYHA) functional class at 24 weeks (NYHA Functional Class is a score from 1 to 4 where higher scores connote worse health-related impairment)
Change in right ventricular morphology by echocardiogram (right ventricular dilation)
To determine whether valsartan improves right ventricular morphology at 24 weeks including improved right ventricular dilation
Change in right ventricular morphology by echocardiogram (tricuspid annular plane systolic excursion(TAPSE))
To determine whether valsartan improves right ventricular morphology at 24 weeks including improved TAPSE
Change in invasive hemodynamics (sub-study): Stroke Volume Index
To determine whether valsartan increases stroke volume index at 24 weeks
Change in invasive hemodynamics (sub-study): Wedge pressure
Exploratory: To explore whether valsartan is associated with differences in wedge pressure at 24 weeks
Change in invasive hemodynamics (sub-study): Right Atrial pressure
Exploratory: To explore whether valsartan is associated with differences in right atrial pressure at 24 weeks
Change in invasive hemodynamics (sub-study): Pulmonary Vascular Resistance
Exploratory: To explore whether valsartan is associated with differences in pulmonary vascular resistance at 24 weeks
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University of Washington
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
