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

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).

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01091012

Enrollment

Registered

2010-03-23

Start date

2011-09-30

Completion date

2013-02-28

Last updated

2012-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

DRUGSildenafil 20mg oral vs Sildenafil 10mg intravenous

2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

Spain

Contacts

Primary ContactEnric Domingo, Promotor

edrcg@hotmail.com00-34-93-2746455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026