NCT00862043

Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease

Sildenafil for Improving Outcomes After Valvular Correction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical efficacy of the mid-term treatment with sildenafil in patients with persistent moderate or severe pulmonary hypertension (PH) after a heart valve intervention.

Detailed description

Phase IV, prospective, multicenter, randomized, double-blind, placebo-controlled, academically funded clinical trial, with 6 months follow-up. A total of 354 patients will be recruited. Inclusion criteria are: 1) successful surgical or percutaneous repair of a cardiac valve at least one year before screening and 2) persistent moderate or severe PH, and 3) absence of any residual significant valvular lesion. Patients will be randomized 1:1 to received sildenafil 40 mg t.i.d. or placebo. The primary endpoint is a clinical composite score combining: all-cause mortality, hospital admission for heart failure, World Health Organization (WHO) functional class, and the patient global assessment score. Additional clinical and mechanistic secondary end-points are defined.

Conditions

• Pulmonary Hypertension
• Valvular Heart Disease

Interventions

Type	Name	Description
DRUG	Sildenafil Citrate	40 mg t.i.d.
DRUG	Placebo	Placebo t.i.d.

Timeline

• Start date: 2009-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2009-03-16
• Last updated: 2016-09-23

Locations

18 sites across 1 country: Spain