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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patient with diagnosed rheumatic valvular heart disease 2. Age between 18-\> 80 years 3. Severe pulmonary hypertension Who Should NOT Join This Trial: 1. Patient undergoing corrective surgery within 6 weeks 2. Uncontrolled hypertension (\>170/110mmHg) 3. Hypotension (Blood pressure of \< 90/50mmHg) 4. Heart Failure or Coronary Arterial Diseases with Unstable Angina 5. Hypersensitivity to sildenafil or any component of the formulation of sildenafil 6. Prior episode of non-arteritic anterior ischemic neuropathy 7. Stroke in last 6 months 8. Life-threatening arrhythmias 9. MI in last 6 months 10. Patient takes nitrates as essential drug therapy 11. Patient doesn't have a plan for corrective surgery within 6 weeks Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patient with diagnosed rheumatic valvular heart disease 2. Age between 18-\> 80 years 3. Severe pulmonary hypertension Exclusion Criteria: 1. Patient undergoing corrective surgery within 6 weeks 2. Uncontrolled hypertension (\>170/110mmHg) 3. Hypotension (Blood pressure of \< 90/50mmHg) 4. Heart Failure or Coronary Arterial Diseases with Unstable Angina 5. Hypersensitivity to sildenafil or any component of the formulation of sildenafil 6. Prior episode of non-arteritic anterior ischemic neuropathy 7. Stroke in last 6 months 8. Life-threatening arrhythmias 9. MI in last 6 months 10. Patient takes nitrates as essential drug therapy 11. Patient doesn't have a plan for corrective surgery within 6 weeks

Treatments Being Tested

DRUG

Sildenafil 25 MG

Thrice a day

DRUG

Placebo

Thrice a day

Locations (1)

Sindh Institute of Cardiovascular Diseases
Hyderābād, Sindh, Pakistan