NCT07462260CompletedPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 5 Mar 2026
- Start date
- 1 Aug 2025
- Primary completion date
- 23 Sept 2026
- Lead sponsor
- Sindh Institute of Cardiovascular Diseases
- NCT number
- NCT07462260
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 100
- From 1 Aug 2025 to the primary completion date, 23 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient undergoing corrective surgery within 6 weeks
- Prior episode of non-arteritic anterior ischemic neuropathy
- Patient takes nitrates as essential drug therapy
- Patient doesn't have a plan for corrective surgery within 6 weeks
Other illness
- Uncontrolled hypertension (\>170/110mmHg)
- Heart Failure or Coronary Arterial Diseases with Unstable Angina
- Hypersensitivity to sildenafil or any component of the formulation of sildenafil
- Stroke in last 6 months
- Life-threatening arrhythmias
Other
- Hypotension (Blood pressure of \< 90/50mmHg)
- MI in last 6 months
Who the study is looking for
- Patient with diagnosed rheumatic valvular heart disease
- Age between 18-\> 80 years
- Severe pulmonary hypertension
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sindh Institute of Cardiovascular Diseases Coordinator of this site? Confirm its status | Hyderābād | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.