Back to resultsSildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery (SiPaHCS)
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension
Eligibility 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
Sites / Locations
- San Giovanni Battista Hospital University of Turin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sildenafil
Arm 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.
Outcomes
Primary Outcome Measures
reduced mechanical ventilation
The primary outcome is the reduction of time on mechanical ventilation
Secondary Outcome Measures
ICU length of stay
The secondary outcome is to evaluate the reduction of intensive care unit length of stay.
Full Information
NCT ID
NCT01481350
First Posted
November 25, 2011
Last Updated
December 6, 2014
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT01481350
Brief Title
Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery
Acronym
SiPaHCS
Official Title
Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.
Primary Outcome Measure Information:
Title
reduced mechanical ventilation
Description
The primary outcome is the reduction of time on mechanical ventilation
Time Frame
seven days
Secondary Outcome Measure Information:
Title
ICU length of stay
Description
The secondary outcome is to evaluate the reduction of intensive care unit length of stay.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Rinaldi, MD
Organizational Affiliation
San Giovanni Battista, Hospital University of Turin
Official's Role
Study Chair
Facility Information:
Facility Name
San Giovanni Battista Hospital University of Turin
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery
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