CompletedNot Applicable

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

United States53 participantsStarted 2009-06

Plain-language 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.

Who can participate

Age range8 Years – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in peak oxygen consumption (from baseline to post-study drug testing)

Timeframe: 4 weeks

Trial details

NCT IDNCT00974025

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

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