Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID06053580

Repurposing Valsartan May Protect Against Pulmonary Hypertension

Led by University of Washington · Updated on 2026-05-04

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pulmonary arterial hypertension (PAH) causes strain on the right side of the heart, which can lead to right heart failure. Unlike left heart failure, there are currently no treatments directly targeting right heart function. Researchers are evaluating valsartan, a medication typically used for high blood pressure and left heart failure, to see if it can help strengthen the right heart in adults with PAH. This is a Phase 2 randomized placebo-controlled trial studying valsartan's safety and clinical effect over 24 weeks. Participants will be randomly assigned to take either valsartan 40 mg capsules or placebo capsules twice daily for 24 weeks. Study visits will occur at weeks 0, 2, 12, and 24, with most visits lasting 20 to 30 minutes in addition to usual clinic appointments. While visits at weeks 2 and 12 may be done remotely, echocardiograms will be done at the start and end of the study. Some participants may choose to undergo optional exercise testing or right heart catheterization at weeks 0 and 24. During the study, participants will be monitored through clinical assessments including echocardiograms and questionnaires about heart function and quality of life. The main outcome measured is the six-minute walk distance over 24 weeks. Secondary outcomes include changes in heart function measurements, heart failure classification, biomarkers, quality of life scores, and frequency of increased pulmonary hypertension treatments. The total participation time is 24 weeks, with safety and clinical data collected throughout.

CONDITIONS

Brief Title

Repurposing Valsartan May Protect Against Pulmonary Hypertension

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, age 18 to 80
  • Diagnosed with WHO Group 1 Pulmonary Arterial Hypertension
  • NYHA Functional Class II, III, or IV at screening
  • Right heart catheterization within five years showing mean pulmonary arterial pressure 6 25 mmHg, occlusion pressure 6 15 mmHg, and resistance 6 3 wood units
  • If occlusion pressure is 15 - 20 mmHg, pulmonary vascular resistance 6 9 wood units and receiving PAH-specific therapy
  • Able to walk at least 50 meters with or without a walking aid
Not Eligible

You will not qualify if you...

  • Pregnant or lactating
  • Pulmonary hypertension other than group 1 or veno-occlusive disease
  • History of interstitial lung disease unless specific lung function criteria met
  • Use of investigational drug or device within 30 days or during study
  • Use of ACE-inhibitor, ARB, or ARNI within 30 days before randomization
  • Left heart disease with ejection fraction less than 40%
  • Any other serious illness or abnormal labs that may risk participant or affect study data
  • Expected survival less than 1 year due to other diseases
  • Allergy or angioedema related to ACE-inhibitors
  • Potassium level above 5 mEq/L or serum creatinine above 2 mg/dL at screening
  • Systolic blood pressure below 90 mmHg at screening

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants take valsartan or placebo twice daily to evaluate its effect on right heart function.

4 study visits at weeks 0, 2, 12, and 24; visits at weeks 2 and 12 may be completed remotely

Trial Site Locations

Total: 1 location

1

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

L

Laurie Hogl, RRT

N

Nancy Liston, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Renin-Angiotensin-Aldosterone System Inhibitor Use and Mortality in Pulmonary Hypertension: Insights From the Veterans Affairs Clinical Assessment Reporting and Tracking Database.

Tim Lahm, Edward Hess, Anna E Barón...

https://pubmed.ncbi.nlm.nih.gov/33031831