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

This study has been completed.
Sponsor:
Collaborator:
Griese-Hutchinson Champions for Children's Hearts Investigator Award
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00974025
First received: September 9, 2009
Last updated: October 20, 2011
Last verified: September 2009

September 9, 2009
October 20, 2011
June 2009
November 2009   (final data collection date for primary outcome measure)
Change in peak oxygen consumption (from baseline to post-study drug testing) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974025 on ClinicalTrials.gov Archive Site
  • Oxygen Pulse [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Peak Work [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Endo-PAT score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Framingham Modified Endothelial Function Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • PedsQL 4.0 - quality of life assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • BNP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
Vitamin C May Improve Endothelial Function and Exercise Capacity in Functional Single Ventricle Patients After Fontan Palliation

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.

Recent evidence suggests that after Fontan operation, single ventricle patients have impaired function of the vascular endothelium due in part to abnormalities in nitric oxide signaling. Endothelial dysfunction may contribute to the development of congestive heart failure and exercise intolerance that have been well-documented in Fontan patients. Therapeutic interventions to improve endothelial function in adults with heart failure have mainly focused on increasing the synthesis or decreasing the degradation of nitric oxide. We propose a randomized, prospective, placebo-controlled trial of vitamin C, an antioxidant that protects NO deactivation, in subjects with single ventricular anatomy after Fontan palliation. The specific aims of this study are to compare NO signaling, endothelial function and exercise capacity in Fontan subjects to that of a control group that is frequency-matched to case subjects by age and sex, and to assess NO signaling, endothelial function and exercise capacity in Fontan subjects after 4 weeks of oral vitamin C (or placebo) therapy. These results have particular importance because improving the endothelial response in Fontan patients has the potential to reduce the risk of developing congestive heart failure and improve exercise capacity. Furthermore, assessing endothelial function and the effects of therapies aimed at improving vascular health may be generalizable to many other chronic pediatric conditions associated with increased cardiovascular risk such as obesity, diabetes mellitus, and hypertension.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fontan Procedure
  • Hypolpastic Left Heart Syndrome
  • Tricuspid Atresia
  • Drug: Vitamin C
    High-dose Vitamin C will be administered in 4 age-based dosing groups
  • Drug: Placebo
    Placebo will be administered twice daily for four weeks
  • Experimental: Vitamin C
    High-dose Vitamin C in 4 age-based doses will be given in two-daily doses for four weeks
    Intervention: Drug: Vitamin C
  • Placebo Comparator: Placebo
    Placebo will be given in two-daily doses for four weeks
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
March 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
8 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00974025
HUM00029464
No
John R. Charpie, University of Michigan Health System
University of Michigan
Griese-Hutchinson Champions for Children's Hearts Investigator Award
Study Director: John R Charpie, MD University of Michigan
Principal Investigator: Bryan H Goldstein, MD University of Michigan
University of Michigan
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP