NCT06053580

Repurposing Valsartan May Protect Against Pulmonary Hypertension

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pulmonary arterial hypertension (PAH) is one of many conditions that put stress and strain on the right side of the heart. This stress and strain can cause right heart failure. Although there are medications to treat PAH, there are currently no medications that act directly on the heart to improve right heart function. This is different than left heart failure where one of the cornerstones of treatment is medication targeted at the heart to improve left heart function. Valsartan is a well-tolerated and inexpensive medication that is currently used to treat hypertension and left heart failure. Preliminary results suggest that valsartan may help the right heart to adapt and strengthen when stressed instead of fail; however, these results are suggestive and not definitive. A randomized controlled trial is required to evaluate the possibility that valsartan can impact right heart function. 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. These visits will add 20-30 minutes to the standard clinic visits at those time points and there will be an echocardiogram at weeks 0 and 24. The visits at weeks 2 and 12 may be completed remotely for most participants. Some participants may elect to participate in exercise testing and/or right heart catheterization at weeks 0 and 24; however, this is not required to participate in the trial.

Conditions

• Pulmonary Arterial Hypertension
• Right Heart Failure
• Right Ventricular Dysfunction
• Pulmonary Vascular Disorder

Interventions

Type	Name	Description
DRUG	Valsartan 40 mg	Valsartan 40mg twice daily for 24 weeks.
DRUG	Placebo	Placebo twice daily for 24 weeks.

Timeline

• Start date: 2024-02-28
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2023-09-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study