Repurposing Valsartan May Protect Against Pulmonary Hypertension

Launched by UNIVERSITY OF WASHINGTON · Sep 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called valsartan can help protect against pulmonary arterial hypertension (PAH), a serious condition that affects the blood vessels in the lungs and can lead to heart failure. The study will last for 24 weeks and will look at how safe valsartan is and how well it works for adults aged 18 to 80 who have been diagnosed with PAH. Participants will be randomly assigned to receive either valsartan or a placebo (a pill that looks the same but has no active medication) to compare the effects.

To be eligible for the trial, individuals must have a specific type of pulmonary hypertension and be able to walk a short distance, among other criteria. However, there are certain conditions that would prevent someone from participating, such as being pregnant or having specific heart or lung issues. Those who join the study can expect regular check-ups and monitoring throughout the trial period to ensure their safety and gather important information about the effects of the medication. This research could provide valuable insights into new treatments for PAH, helping to improve care for patients in the future.

Gender

ALL

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