RecruitingPhase 2Phase 3NCT07462260

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Efficacy of Sildenafil in Severe Pulmonary Hypertension Secondary to Rheumatic Chronic Valvular Disease: A Double-Blinded Placebo Randomized Control Trial


Sponsor

Sindh Institute of Cardiovascular Diseases

Enrollment

100 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Pulmonary hypertension secondary to left heart disease is associated with increased morbidity and mortality, particularly in patients with rheumatic chronic valvular heart disease, which remains highly prevalent in low- and middle-income countries. These patients often present late with severe pulmonary hypertension, limiting surgical options and worsening outcomes. Sildenafil, a phosphodiesterase-5 inhibitor, has demonstrated benefit in various forms of pulmonary hypertension; however, its role in pulmonary hypertension secondary to rheumatic valvular disease remains inadequately studied. This double-blind, placebo-controlled randomized clinical trial aims to evaluate the efficacy and safety of sildenafil as an adjunct to standard medical therapy in patients with severe pulmonary hypertension due to rheumatic chronic valvular heart disease. Eligible participants will be randomized in a 1:1 ratio to receive either sildenafil (25 mg three times daily) or placebo for six weeks. The primary outcome is change in six-minute walk distance, while secondary outcomes include changes in right ventricular function and dimensions, systolic pulmonary artery pressure, NYHA functional class, and hospitalization rates. The study seeks to generate evidence to support medical optimization and bridging therapy in this high-risk population awaiting definitive surgical intervention.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether sildenafil (a drug commonly used for pulmonary arterial hypertension and erectile dysfunction) can help lower dangerously high blood pressure in the lungs in patients with rheumatic heart valve disease — a condition where past rheumatic fever has damaged the heart valves. **You may be eligible if...** - You have been diagnosed with rheumatic valvular heart disease - You are between 18 and 80+ years old - You have severe pulmonary hypertension (high blood pressure in the lungs) - You are planning to have corrective surgery within 6 weeks **You may NOT be eligible if...** - You have uncontrolled high blood pressure (above 170/110 mmHg) - You have very low blood pressure (below 90/50 mmHg) - You have had a stroke in the last 6 months - You have had a heart attack in the last 6 months - You take nitrate medications (such as nitroglycerin) - You have certain other serious heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSildenafil 25 MG

Thrice a day

DRUGPlacebo

Thrice a day


Locations(1)

Sindh Institute of Cardiovascular Diseases

Hyderābād, Sindh, Pakistan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07462260


Related Trials