A Phase 2 interventional study of Valsartan 40 mg and Placebo in Pulmonary Arterial Hypertension, Right Heart Failure and Right Ventricular Dysfunction, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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.
Pulmonary arterial hypertension (PAH) is one of many conditions that put stress and strain on the right side of the heart. This stress and strain can cause right heart failure. Although there are medications to treat PAH, there are currently no medications that act directly on the heart to improve right heart function. This is different than left heart failure where one of the cornerstones of treatment is medication targeted at the heart to improve left heart function.
Valsartan is a well-tolerated and inexpensive medication that is currently used to treat hypertension and left heart failure. Preliminary results suggest that valsartan may help the right heart to adapt and strengthen when stressed instead of fail; however, these results are suggestive and not definitive. A randomized controlled trial is required to evaluate the possibility that valsartan can impact right heart function.
Participants in the study will take valsartan or placebo for 24 weeks. They will have three study visits at 0, 2, 12, and 24 weeks. These visits will add 20-30 minutes to the standard clinic visits at those time points and there will be an echocardiogram at weeks 0 and 24. The visits at weeks 2 and 12 may be completed remotely for most participants. Some participants may elect to participate in exercise testing and/or right heart catheterization at weeks 0 and 24; however, this is not required to participate in the trial.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Valsartan 40mg capsule taken twice daily for 24 weeks.
Drug: Valsartan 40 mg
Placebo capsule taken twice daily for 24 weeks.
Drug: Placebo
Valsartan 40mg twice daily for 24 weeks.
Also known as: Diovan
Placebo 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.
Time frame: 0 to 24 weeks
Change in BNP
To determine whether valsartan reduces BNP at 24 weeks
Time frame: 0 to 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)
Time frame: 0 to 24 weeks
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
Time frame: 0 to 24 weeks
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
Time frame: 0 to 24 weeks
Change in health related quality of life (emPHasis-10 questionnaire)
To determine whether valsartan improves health related quality of life as estimated by the emPHasis- 10 score (Each item on the emPHasis-10 questionnaire is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end; EmPHasis-10 scores range from 0 to 50 with higher scores indicating worse quality of life)
Time frame: 0 to 24 weeks
Frequency of escalation for PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding additional pulmonary vasodilators)
To determine whether valsartan decreases the need to escalate PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding an additional pulmonary vasodilator)
Time frame: 0 to 24 weeks
Change in invasive hemodynamics (sub-study): Stroke Volume Index
To determine whether valsartan increases stroke volume index at 24 weeks
Time frame: 0 to 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
Time frame: 0 to 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
Time frame: 0 to 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
Time frame: 0 to 24 weeks
Change in Cardiopulmonary Exercise Testing (sub-study): Maximal oxygen uptake
To determine whether valsartan increases maximal oxygen uptake in individuals with pulmonary arterial hypertension at 24 weeks
Time frame: 0 to 24 weeks
Change in Cardiopulmonary Exercise Testing (sub-study): Ve/VCO2 slope
Exploratory: To explore whether valsartan decreases the Ve/VCO2 slope in individuals with pulmonary arterial hypertension over 24 weeks
Time frame: 0 to 24 weeks
Change in Cardiopulmonary Exercise Testing (sub-study): Total wattage
Exploratory: To explore whether valsartan increases total achieved wattage in individuals with pulmonary arterial hypertension over 24 weeks
Time frame: 0 to 24 weeks
Plan to share: No
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Studies of the drug tested here: Valsartan
Pulmonary Arterial Hypertension →