Study of Sildenafil Added to Standard Therapy for Severe Pulmonary Hypertension Caused by Rheumatic Valvular Heart Disease

What this Trial Is About

Pulmonary hypertension caused by left heart disease, especially due to rheumatic chronic valvular heart disease, leads to increased health problems and death, mainly in low- and middle-income countries. Many patients arrive late with severe pulmonary hypertension, which complicates surgery and worsens outcomes. Sildenafil, a drug that relaxes blood vessels, has shown benefits for some pulmonary hypertension types but its effect in this specific condition is not well studied. This trial aims to test sildenafils safety and effectiveness as an add-on treatment for severe pulmonary hypertension from rheumatic chronic valvular disease in a controlled setting. Participants will be randomly assigned to receive either sildenafil 25 mg three times daily or a placebo, alongside standard medical care, for six weeks. The study uses a double-blind design, so neither patients nor researchers know who receives sildenafil or placebo. Standard therapy includes treatment for rheumatic fever, diuretics, and heart failure care as needed. The trial is conducted at specialized cardiology centers, and outcome assessments are done by independent, blinded teams. During the study, participants will be monitored for changes in their walking capacity measured by a six-minute walk test, heart and lung function via echocardiography, pulmonary artery pressure, symptom severity by NYHA class, and hospitalization rates. Medication adherence and side effects will be regularly checked by phone. The trial includes safety measures to stop treatment if significant harm is detected. The total participation lasts six weeks with close follow-up to collect all outcome data.

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