Sildenafil for severe pulmonary hypertension from rheumatic valve disease
Efficacy of Sildenafil in Severe Pulmonary Hypertension Secondary to Rheumatic Chronic Valvular Disease: A Double-Blinded Placebo Randomized Control Trial
This trial will test whether sildenafil improves symptoms and exercise capacity in adults with severe pulmonary hypertension caused by rheumatic valvular heart disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiovascular Diseases, Pakistan Academic / other |
| Locations | 1 site (Hyderābād, Sindh) |
| Trial ID | NCT07462260 on ClinicalTrials.gov |
What this trial studies
This double-blind, placebo-controlled, randomized trial will enroll adults (18-80) with rheumatic valvular heart disease and severe pulmonary hypertension and randomize them 1:1 to sildenafil 25 mg three times daily or placebo for six weeks as an adjunct to standard medical care. The study is conducted at the adult cardiology and cardiac surgery departments of the Sindh Institute of Cardiovascular Diseases in Hyderabad, Pakistan. Key outcomes include exercise capacity measured by the six-minute walk distance and safety/tolerability over the six-week treatment period. The design aims to determine whether short-term pulmonary vasodilation with sildenafil can improve functional status and help bridge patients while they await corrective valve surgery.
Who should consider this trial
Good fit: Adults aged 18-80 with diagnosed rheumatic valvular heart disease and severe pulmonary hypertension who are not scheduled for corrective surgery within six weeks and who meet the study inclusion/exclusion criteria.
Not a fit: Patients taking essential nitrates, with recent myocardial infarction or stroke, uncontrolled blood pressure, life-threatening arrhythmias, or other listed exclusions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, sildenafil could improve exercise tolerance and symptoms and may reduce perioperative risk while patients wait for valve surgery.
How similar studies have performed: Sildenafil has demonstrated benefit in pulmonary arterial hypertension and some secondary forms of pulmonary hypertension, but evidence specifically for pulmonary hypertension due to rheumatic valvular disease is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hyderābād, Sindh
- Sindh Institute of Cardiovascular Diseases — Hyderābād, Sindh, Pakistan (Recruiting)
Study contacts
- Study coordinator: Dr Aamir Khuwaja
- Email: khuwaja.aamir91@gmail.com
- Phone: 03323594539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.