Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension
Phase 3
- Conditions
- Pulmonary Hypertension
- Interventions
- Registration Number
- NCT01091012
- 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
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vall Hebron Hospital
🇪🇸Barcelona, Spain