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

Phase 2

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: sildenafil

• Registration Number: NCT01481350
• Lead Sponsor: University of Turin, Italy

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.

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 Timeline

• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Study Start: 2012-02
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-06
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sildenafil	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.

Primary Outcome Measures

Name	Time	Method
reduced mechanical ventilation	seven days	The primary outcome is the reduction of time on mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	28 days	The secondary outcome is to evaluate the reduction of intensive care unit length of stay.

Trial Locations

Locations (1)

San Giovanni Battista Hospital University of Turin; 🇮🇹 Turin, Italy