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

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

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

Conditions3

Interventions1

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