Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for
This trial is looking for adults with pulmonary arterial hypertension. Participating involves taking valsartan for 24 weeks to see if it helps with their condition.
Are You a Good Fit for This Trial?
Must not be takingACE-inhibitorsARBs
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with pulmonary arterial hypertension.
I have a functional class of II, III, or IV.
I had a heart catheterization in the last five years showing certain pressure levels.
I can walk at least 50 meters with or without a walking aid.
You may not be able to join if
I am pregnant or breastfeeding.
I have a different type of pulmonary hypertension.
I have a history of serious lung disease.
I have taken investigational drugs in the past 30 days.
I have used ACE-inhibitors or ARBs in the past 30 days.
My left ventricle function is low.
I have significant health issues that raise study risks.
My expected survival is less than one year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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
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