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

Sponsor

University of Turin, Italy (Other)

Overall Status

Completed

CT.gov ID

NCT01481350

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Drug: sildenafil	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: sildenafil The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.

Arm

Intervention/Treatment

Experimental: 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.

Drug: sildenafil

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

Outcome Measures

Primary Outcome Measures

reduced mechanical ventilation [seven days]
The primary outcome is the reduction of time on mechanical ventilation

Secondary Outcome Measures

ICU length of stay [28 days]
The secondary outcome is to evaluate the reduction of intensive care unit length of stay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Giovanni Battista Hospital University of Turin	Turin		Italy	10126

Sponsors and Collaborators

University of Turin, Italy

Investigators

Study Chair: Mauro Rinaldi, MD, San Giovanni Battista, Hospital University of Turin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniela Pasero, Medical Doctor, University of Turin, Italy

ClinicalTrials.gov Identifier:

NCT01481350

Other Study ID Numbers:

0064280

First Posted:

Nov 29, 2011

Last Update Posted:

Dec 9, 2014

Last Verified:

Dec 1, 2014

Additional relevant MeSH terms:

Hypertension, Pulmonary

Hypertension

Sildenafil Citrate

Study Results

No Results Posted as of Dec 9, 2014