prognostic effect of sildenafil in patients with severe mitral stenosis and reactive pulmonary hypertension candidate for mitral valve replacement at Tehran Heart Center

Comparison of sildenafil effects and placebo on mortality and morbidity in patients with severe mitral stenosis and reactive pulmonary hypertension after mitral valve replacement

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014072818625N1

Enrollment

Registered

2014-09-09

Start date

2014-09-06

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Reactive Pulmonary Hypertension. Condition 2: severe mitral stenosis. Other specified pulmonary heart diseases Mitral stenosis

Interventions

Intervention 1: Patients with severe mitral stenosis and reactive pulmonary hypertension, who are candidate for elective mitral valve replacement using a 1: 1 method, are randomly divided into two gro

Treatment - Drugs

Placebo

Second (control) group will receive placebo during study period.

Patients with severe mitral stenosis and reactive pulmonary hypertension, who are candidate for elective mitral valve replacement using a 1: 1 method, are randomly divided into two groups: Group 1(int

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with severe mitral stenosis; Pulmonary artery pressure more than 35 mm Hg in trans esophageal echocardiography; Reactive pulmonary hypertension according right heart catheterization (difference between mean pulmonary artery pressure and Pulmonary Capillary Wedge Pressure> 12mmhg) Exclusion criteria: Necessity of nitrate; Significant hypotension after first dose of sildensfil; Mitral regurgitation more severe than moderate degree; Necessity of aortic or tricuspid valve replacement; Concomitant Coronary artery bypasses graft surgery

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pulmonary Artery Pressure. Timepoint: 7 days before mitral valve replacement/ 6 week after mitral valve replacement. Method of measurement: Transthoracic Echocardiography.;Left Ventricular Ejection Fraction. Timepoint: 7 days before mitral valve replacement/ 6 week after mitral valve replacement. Method of measurement: Transthoracic Echocardiography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTahereh davarpasand

Tehran Heart Center

tahereh.davarpasand@yahoo.com; davarpasand@sina.tums.ac.ir+98 21 8802 9600

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026