Pulmonary Hypertension Clinical Trial
Official title:
Study About Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension, at Last Moderate and Secondary at Valve Disease(Corrected With a Normally Functioning Prosthesis).
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | February 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Spain | Vall Hebron Hospital | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitari Vall d'Hebron Research Institute |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effectiveness | The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance. | one day per patient | No |
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|---|---|---|---|
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