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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Unknown; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT01091012

2009-012005-19 (EudraCT Number)

DOM-SIL-2009

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Sildenafil 20mg oral

Other group

Treatment:

Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous

Sildenafil 10mg intravenous

Other group

Treatment:

Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous