Repurposing Valsartan May Protect Against Pulmonary Hypertension
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.
Conditions:
🦠 Pulmonary Arterial Hypertension 🦠 Right Heart Failure 🦠 Right Ventricular Dysfunction 🦠 Pulmonary Vascular Disorder
🗓️ Study Start (Actual) 28 February 2024
🗓️ Primary Completion (Estimated) 1 July 2027
✅ Study Completion (Estimated) 1 July 2027
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Seattle, Washington, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 September 2023
  • First Submitted that Met QC Criteria 13 September 2023
  • First Posted 25 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 March 2024
  • Last Update Posted 15 March 2024
  • Last Verified March 2024