Overview

Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients

Status:
Completed
Trial end date:
0000-00-00
Target enrollment:
53
Participant gender:
Both
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 physiology. The hypothesis is that vitamin C will result in improved exercise tolerance and endothelial function in patients who have undergone the Fontan operation, compared to placebo.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Michigan
Collaborator:
Griese-Hutchinson Champions for Children's Hearts Investigator Award
Treatments:
Ascorbic Acid
Vitamins
Last Updated:
2011-10-20
Criteria
Inclusion Criteria:

- 8-25 years of age

- Fontan-palliated patient

Exclusion Criteria:

- 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