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Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease

2014-07-24 14:14:02 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Pulmonary Hypertension

Intervention

Sildenafil Citrate, Placebo

Location

Hospital Son Dureta
Palma de Mallorca
Mallorca
Spain
28007

Status

Recruiting

Source

Hospital General Universitario Gregorio Marañon

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:14:02-0400

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