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

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.

NCT Number	NCT07462260
Lead Sponsor	Sindh Institute of Cardiovascular Diseases Collaborators: National Institute of Cardiovascular Diseases
Conditions	Pulmonary Hypertension, Rheumatic Valvular Heart Disease
Enrollment	100 participants
Start Date	2025-08-01
Primary Completion	2026-04 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-10