NCT06053580 Repurposing Valsartan May Protect Against Pulmonary Hypertension
| NCT ID | NCT06053580 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Washington |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-02-28 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Peter Leary, MD, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06053580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06053580 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06053580 currently recruiting?
Yes, NCT06053580 is actively recruiting participants. Contact the research team at lalnaser@uw.edu for enrollment information.
Where is the NCT06053580 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06053580 clinical trial?
NCT06053580 is sponsored by University of Washington. The principal investigator is Peter Leary, MD, PhD at University of Washington. The trial plans to enroll 60 participants.