Repurposing Valsartan May Protect Against Pulmonary Hypertension
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 3 visits
- Time periods mentioned: 24 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether valsartan is safe and helps adults with pulmonary arterial hypertension, or high blood pressure in the lung arteries. Adults ages 18 to 80 will be assigned by chance to take valsartan or a placebo (a pill with no study drug) for 24 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 80 years old.
- You have WHO Group 1 pulmonary arterial hypertension.
- Your symptoms limit physical activity or happen at rest (NYHA Class II, III, or IV).
- A right heart catheter test within the past 5 years must show certain lung blood pressure levels: average artery pressure at least 25 mmHg, occlusion pressure at most 15 mmHg, and resistance to blood flow at least 3 Wood units.
- If your occlusion pressure is 15–20 mmHg, you may still qualify if average lung artery pressure is at least 25 mmHg, resistance is at least 9 Wood units, and you take treatment specifically for pulmonary arterial hypertension.
- You can walk at least 50 meters, with or without a walking aid.
Who can't join
- You are pregnant or breastfeeding.
- You have pulmonary hypertension other than Group 1, or disease that blocks the small veins in your lungs.
- You have a history of interstitial lung disease (lung scarring), unless you also have collagen vascular disease (a disease affecting connective tissue) and a lung test within 12 months shows total lung capacity or vital capacity of at least 60%.
- You have taken part in another study or used an experimental drug or device within 30 days, or will do so during this study.
- You used an ACE inhibitor, ARB, or ARNI (types of heart or blood pressure medicines) within 30 days before study group assignment, or have had an allergy or angioedema (swelling under the skin) from an ACE inhibitor.
- You have disease on the left side of your heart, with a pumping measure called ejection fraction below 40%.
- You have another serious illness or abnormal test results that the study doctor thinks could make the study unsafe or affect its results, or another illness means you are expected to live less than 1 year.
- At screening, your potassium is above 5 mEq/L, your creatinine (a kidney function blood test) is above 2 mg/dL, or the top number of your blood pressure is below 90 mmHg.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Male or female, age 18 to 80 2. WHO Group 1 Pulmonary Arterial Hypertension 3. NYHA Functional Class II, III, or IV at screening (Appendix 2 for Functional Class Decision Aid) 4. 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 5. 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 6. Able to walk with/without a walking aid for a distance of at least 50 meters Exclusion Criteria: 1. Pregnant or lactating 2. Non-group 1 pulmonary hypertension or veno-occlusive disease 3. 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 % 4. Has received or will receive an investigational drug, device, or study within 30 days or during the course of study 5. ACE-inhibitor, ARB or ARNI use within 30 days of randomization. 6. Left sided myocardial disease as evidenced by left ventricular ejection fraction \< 40% 7. 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 8. Anticipated survival less than 1 year due to concomitant disease 9. Allergy or angioedema with ACE-inhibitor use 10. Potassium \>5mEq/L or sCr \>2mg/dL at screening 11. SBP \<90mmHg at screening
Study sites (1)
WA
- University of Washington Medical Center · Seattle, WA 98195Laurie Hogl · Study contact · 2065438334 · lalnaser@uw.eduPeter J Leary, MD, PhD · Principal investigatorYonatan Buber, MD · Sub-investigatorSam G Rayner, MD · Sub-investigatorMore trials in Seattle