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Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery

NCT ID: NCT01481350

Last Updated: 2014-12-09

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

Brief Summary

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Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac surgery for valvular heart diseases, especially in patients with a long life mitral valve disease. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.

Detailed Description

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Pulmonary hypertension represents an increased risk for perioperative patients undergoing cardiac surgery for valvular heart disease especially in patients with a long life mitral valve disease complicated by sever pulmonary hypertension, with high risk of developing post operative right ventricular failure during separation from cardiopulmonary by pass. A recent study showed that a single oral administration of sildenafil at the beginning of the cardiac intervention in patients undergoing valvular heart surgery complicated by pulmonary hypertension reduces pulmonary vascular resistances without inducing significant effects on systemic vascular resistances. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle avoiding right ventricular failure. This should support weaning from cardiopulmonary by pass in patients undergoing cardiac surgery for valvular heart diseases associated to pulmonary hypertension.

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sildenafil

All patient will be treat with a intravenous administration of the drug from the beginning of the intervention, for a maximum of 72 hours.

Group Type EXPERIMENTAL

sildenafil

Intervention Type DRUG

The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.

Interventions

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sildenafil

The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all patients undergoing valvular heart surgery associated to post capillary pulmonary hypertension with a mean pulmonary arterial pressure (mPAP)\>30mmHg or pulmonary vascular resistance (PVR)\>3Wu.

Exclusion Criteria

* patients younger than 18 years old
* ischemic cardiomyopathy
* Ejection Fraction (EF)\<30%
* severe Chronic obstructive pulmonary disease (COPD) with oxygen and bronchodilators therapy
* chronic pulmonary disease, chronic renal failure on dialysis
* hepatic failure
* patients with orotracheal intubation and already admitted to the ICU before the intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Daniela Pasero

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro Rinaldi, MD

Role: STUDY_CHAIR

San Giovanni Battista, Hospital University of Turin

Locations

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San Giovanni Battista Hospital University of Turin

Turin, Turin, Italy

Site Status

Countries

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Italy

Other Identifiers

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0064280

Identifier Type: -

Identifier Source: org_study_id