NCT07462260 Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)
| NCT ID | NCT07462260 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sindh Institute of Cardiovascular Diseases |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-08-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Dr Jawaid Akbar Sial
STUDY DIRECTOR
Sindh Institute of Cardiovascular Diseases
Frequently Asked Questions
Who can join the NCT07462260 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07462260 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07462260 currently recruiting?
Yes, NCT07462260 is actively recruiting participants. Contact the research team at khuwaja.aamir91@gmail.com for enrollment information.
Where is the NCT07462260 trial being conducted?
This trial is being conducted at Hyderābād, Pakistan.
Who is sponsoring the NCT07462260 clinical trial?
NCT07462260 is sponsored by Sindh Institute of Cardiovascular Diseases. The principal investigator is Dr Jawaid Akbar Sial at Sindh Institute of Cardiovascular Diseases. The trial plans to enroll 100 participants.