Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension

Phase 3

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous

• Registration Number: NCT01091012
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

The main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically significant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Study Start: 2011-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-10
• Last Update Posted: 2012-09-11
• Primary Completion: 2012-12
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients clinically stable, at least 1 year after the completion of successful valve surgery, with persistent pulmonary artery systolic pressure> 50 mmHg,
• normal left ventricular function and no significant valvular disease in 2 separate Doppler ultrasound studies at least 1 month.

Exclusion Criteria

• Patients with other cardiac and noncardiac diseases will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil 10mg intravenous	Sildenafil 20mg oral vs Sildenafil 10mg intravenous	-
Sildenafil 20mg oral	Sildenafil 20mg oral vs Sildenafil 10mg intravenous	-

Primary Outcome Measures

Name	Time	Method
Effectiveness	one day per patient	The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance.

Trial Locations

Locations (1)

Vall Hebron Hospital; 🇪🇸 Barcelona, Spain