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Completed

NCT Number: NCT01481350

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Giovanni Battista Hospital University of Turin

Turin, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

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

Primary outcomes

  1. reduced mechanical ventilation

    Time frame: seven days

    The primary outcome is the reduction of time on mechanical ventilation

Secondary outcomes

  1. ICU length of stay

    Time frame: 28 days

    The secondary outcome is to evaluate the reduction of intensive care unit length of stay.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Acronym: SiPaHCS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2011
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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