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

Completed · Not applicable · Has a placebo group

Conditions studied: Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia

In brief

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.

Key facts

Study ID

NCT00974025

Run by

University of Michigan

People needed

53

Starts

2009-06-01

Expected to finish

2010-03-01

Last updated by the study team

2017-06-01

Who can join

Age: 8 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 8-25 years of age
• Fontan-palliated patient

You may not qualify if…

• 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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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