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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Turin, Italy
Sponsor:
Information provided by (Responsible Party):
Daniela Pasero, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01481350
First received: November 25, 2011
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
Drug: sildenafil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • reduced mechanical ventilation [ Time Frame: seven days ] [ Designated as safety issue: No ]
    The primary outcome is the reduction of time on mechanical ventilation


Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The secondary outcome is to evaluate the reduction of intensive care unit length of stay.


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: sildenafil
The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481350

Contacts
Contact: Daniela Pasero, MD +390116335511 daniela.pasero@unito.it
Contact: Francesca Ivaldi, MD +390116335511 franiv@tin.it

Locations
Italy
San Giovanni Battista Hospital University of Turin Recruiting
Turin, Italy, 10126
Contact: Daniela Pasero, MD    00390116335511    daniela.pasero@unito.it   
Contact: Francesca Ivaldi, MD    00390116335511    franiv@tin.it   
Sub-Investigator: Francesca Ivaldi, MD         
Principal Investigator: Daniela Pasero, MD         
Sub-Investigator: Mario Lupo, MD         
Sub-Investigator: Walter Grosso Marra, MD         
Sub-Investigator: Luca Checco, MD         
Sub-Investigator: Nerlep Kaur Rana, MD         
Sponsors and Collaborators
University of Turin, Italy
Investigators
Study Chair: Mauro Rinaldi, MD San Giovanni Battista, Hospital University of Turin
  More Information

No publications provided

Responsible Party: Daniela Pasero, Medical Doctor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01481350     History of Changes
Other Study ID Numbers: 0064280
Study First Received: November 25, 2011
Last Updated: February 13, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 16, 2014