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

Pulmonary Hypertension Clinical Trial

— SiPaHCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481350
• Other study ID #: 0064280
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2011
• Last updated: December 6, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
Italy	San Giovanni Battista Hospital University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduced mechanical ventilation	The primary outcome is the reduction of time on mechanical ventilation	seven days	No
Secondary	ICU length of stay	The secondary outcome is to evaluate the reduction of intensive care unit length of stay.	28 days	No