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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01481350

Acronym

SiPaHCS

Enrollment

Registered

2011-11-29

Start date

2012-02-29

Completion date

2013-12-31

Last updated

2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

DRUGsildenafil

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
reduced mechanical ventilation	seven days	The primary outcome is the reduction of time on mechanical ventilation

Secondary

Measure	Time frame	Description
ICU length of stay	28 days	The secondary outcome is to evaluate the reduction of intensive care unit length of stay.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026