Repurposing Valsartan May Protect Against Pulmonary Hypertension

NCT06053580 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00018685R61HL167848
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Six-minute walk distance

  To determine whether valsartan increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension.

  0 to 24 weeks

Secondary Outcomes (6)

• Change in BNP

  0 to 24 weeks

• Change in New York Heart Association (NYHA) functional class

  0 to 24 weeks

• Change in right ventricular morphology by echocardiogram (right ventricular dilation)

  0 to 24 weeks

• Change in right ventricular morphology by echocardiogram (tricuspid annular plane systolic excursion(TAPSE))

  0 to 24 weeks

• Change in health related quality of life (emPHasis-10 questionnaire)

  0 to 24 weeks

Other Outcomes (7)

• Change in invasive hemodynamics (sub-study): Stroke Volume Index

  0 to 24 weeks

• Change in invasive hemodynamics (sub-study): Wedge pressure

  0 to 24 weeks

• Change in invasive hemodynamics (sub-study): Right Atrial pressure

  0 to 24 weeks

Study Arms (2)

Valsartan

EXPERIMENTAL

Valsartan 40mg capsule taken twice daily for 24 weeks.

Drug: Valsartan 40 mg

Placebo

PLACEBO COMPARATOR

Placebo capsule taken twice daily for 24 weeks.

Drug: Placebo

Interventions

Valsartan 40 mg DRUG

Valsartan 40mg twice daily for 24 weeks.

Also known as: Diovan

Valsartan

Placebo DRUG

Placebo twice daily for 24 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 to 80
• WHO Group 1 Pulmonary Arterial Hypertension
• NYHA Functional Class II, III, or IV at screening (Appendix 2 for Functional Class Decision Aid)
• 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
• Able to walk with/without a walking aid for a distance of at least 50 meters

You may not qualify if:

• Pregnant or lactating
• Non-group 1 pulmonary hypertension or veno-occlusive disease
• 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 %
• Has received or will receive an investigational drug, device, or study within 30 days or during the course of study
• ACE-inhibitor, ARB or ARNI use within 30 days of randomization.
• Left sided myocardial disease as evidenced by left ventricular ejection fraction \< 40%
• 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
• Anticipated survival less than 1 year due to concomitant disease
• Allergy or angioedema with ACE-inhibitor use
• Potassium \>5mEq/L or sCr \>2mg/dL at screening
• SBP \<90mmHg at screening

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (1)

• Lahm T, Hess E, Baron AE, Maddox TM, Plomondon ME, Choudhary G, Maron BA, Zamanian RT, Leary PJ. Renin-Angiotensin-Aldosterone System Inhibitor Use and Mortality in Pulmonary Hypertension: Insights From the Veterans Affairs Clinical Assessment Reporting and Tracking Database. Chest. 2021 Apr;159(4):1586-1597. doi: 10.1016/j.chest.2020.09.258. Epub 2020 Oct 5.

  PMID: 33031831 BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Heart Failure; Ventricular Dysfunction, Right

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Peter Leary, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Hogl, RRT

CONTACT

206.543.8334; lalnaser@uw.edu

Nancy Liston, MS

CONTACT

206.543.8334; nmliston@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 25, 2023
• Study Start: February 28, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)