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

NCT ID: NCT01091012

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Sildenafil 20mg oral

Group Type OTHER

Sildenafil 20mg oral vs Sildenafil 10mg intravenous

Intervention Type DRUG

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

Sildenafil 10mg intravenous

Group Type OTHER

Sildenafil 20mg oral vs Sildenafil 10mg intravenous

Intervention Type DRUG

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

Interventions

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Sildenafil 20mg oral vs Sildenafil 10mg intravenous

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

Intervention Type DRUG

Other Intervention Names

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REVATIO oral vs REVATIO intravenous

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enric Domingo, Promotor

Role: PRINCIPAL_INVESTIGATOR

Vall Hebron Hospital

Locations

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Vall Hebron Hospital

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Enric Domingo, Promotor

Role: CONTACT

Phone: 00-34-93-2746455

Email: [email protected]

Facility Contacts

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Enric Domingo, Physician

Role: primary

Other Identifiers

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2009-012005-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DOM-SIL-2009

Identifier Type: -

Identifier Source: org_study_id