Overview
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
Status:
Completed
Completed
Trial end date:
0000-00-00
0000-00-00
Target enrollment:
53
53
Participant gender:
Both
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/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University of MichiganCollaborator:
Griese-Hutchinson Champions for Children's Hearts Investigator AwardTreatments:
Ascorbic Acid
VitaminsLast 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