Status:
COMPLETED
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Griese-Hutchinson Champions for Children's Hearts Investigator Award
Conditions:
Fontan Procedure
Hypoplastic Left Heart Syndrome
Eligibility:
All Genders
8-25 years
Phase:
NA
Brief Summary
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan...
Detailed Description
Recent evidence suggests that after Fontan operation, single ventricle patients have impaired function of the vascular endothelium due in part to abnormalities in nitric oxide signaling. Endothelial d...
Eligibility Criteria
Inclusion
- 8-25 years of age
- Fontan-palliated patient
Exclusion
- New York Heart Association (NYHA) classes III or IV
- Diabetes mellitus
- Family history of premature coronary artery disease
- Use of Sildenafil or other pulmonary artery vasodilators
- Prior cardiac arrest (outside the first 24-hours postoperatively)
- Life-threatening dysrhythmias
- Severe ventricular dysfunction
- Severe AV valve regurgitation
- Pregnancy
- Severe renal or hepatic impairment
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00974025
Start Date
June 1 2009
End Date
March 1 2010
Last Update
June 1 2017
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109