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

Study acronym: SERIES
StatusCompleted
PhasePhase 2/3
Started

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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Apr 2026 to Sep 23, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07462260
Lead Sponsor Sindh Institute of Cardiovascular Diseases
Collaborators: National Institute of Cardiovascular Diseases
Conditions
(from sponsor)
Pulmonary Hypertension, Rheumatic Valvular Heart Disease
Related terms Hypertension, Pulmonary
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov