Status:
COMPLETED
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
American Heart Association
Conditions:
Single Ventricle Heart Disease After Fontan Surgery
Eligibility:
All Genders
3-40 years
Phase:
PHASE4
Brief Summary
The study will investigate the cardiovascular effects of sildenafil on patients with Fontan circulation. Recent studies suggest that sildenafil may improve exercise in patients with Fontan circulation...
Detailed Description
Modifications to surgical procedures and medical treatment have led to a rapidly declining mortality rates in patients with single-ventricle heart disease (SV). However, SV patients still suffer from ...
Eligibility Criteria
Inclusion
- Presence of a congenital heart defect that leads to single ventricle physiology
- Previously performed Fontan surgery
Exclusion
- The use of phosphodiesterase type 5 (PDE5) inhibitors at the time of catheterization of within 1 month of catheterization
- Unstable arrhythmia at the time of catheterization
- History of unstable arrhythmia within 2 months of catheterization
- Venous, arterial or cardiac malformation that precludes the proper placement of a microconductance catheter
- Allergy to sildenafil or previous significant adverse reaction to sildenafil (e.g. hypotension)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01815502
Start Date
February 1 2013
End Date
December 1 2014
Last Update
December 7 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425