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

University of Turin

Status and phase: Completed; Phase 2

Conditions: Pulmonary Hypertension

Treatments: Drug: sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01481350

0064280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Sildenafil

Experimental group

Description:

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

Treatment:

Drug: sildenafil