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Congenital heart disease · May 2012
Randomized Controlled TrialImpact of vitamin C on endothelial function and exercise capacity in patients with a Fontan circulation.
- Bryan H Goldstein, Angela M Sandelin, Jessica R Golbus, Nicole Warnke, Lindsay Gooding, Karen K King, Janet E Donohue, Sunkyung Yu, James G Gurney, Caren S Goldberg, Albert P Rocchini, and John R Charpie.
- Division of Cardiology, Department of Pediatrics, C.S. Mott Children's Hospital, University of Michigan Health System, Ann Arbor, MI, USA. bryan.goldstein@cchmc.org
- Congenit Heart Dis. 2012 May 1; 7 (3): 226-34.
Objective To evaluate the impact of antioxidant therapy on functional health status in Fontan-palliated patients. Design. Prospective, randomized, double-blind, placebo-controlled trial.Patients Fifty-three generally asymptomatic Fontan patients.Interventions Patients were randomized to receive either high-dose ascorbic acid (vitamin C) or placebo for 4 weeks.Outcome Measures Peripheral vascular function, as measured with endothelium-dependent digital pulse amplitude testing (EndoPAT), and exercise capacity were assessed before and after study drug treatment. Primary outcome measures included the EndoPAT index and peripheral arterial tonometry (PAT) ratio, both validated markers of vascular function. Secondary outcome measures included peak oxygen consumption and work.Results Twenty-three vitamin C- and 21 placebo-assigned subjects completed the protocol (83%). Median age and time from Fontan completion were 15 (interquartile range [IQR] 11.7-18.2) and 11.9 years (IQR 9.0-15.7), respectively. Right ventricular morphology was dominant in 30 (57%). Outcome measures were similar between groups at baseline. Among all subjects, vitamin C therapy was not associated with a statistical improvement in either primary or secondary outcome measures. In subjects with abnormal vascular function at baseline, compared with placebo, vitamin C therapy more frequently resulted in normalization of the EndoPAT index (45% vs. 17%) and PAT ratio (38% vs. 13%).Conclusions Short-term therapy with vitamin C does not alter endothelial function or exercise capacity in an asymptomatic Fontan population overall. Vitamin C may provide benefit to a subset of Fontan patients with abnormal vascular function.© 2011 Wiley Periodicals, Inc.
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