Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fontan Procedure Hypolpastic Left Heart Syndrome Tricuspid Atresia |
Drug: Vitamin C Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vitamin C May Improve Endothelial Function and Exercise Capacity in Functional Single Ventricle Patients After Fontan Palliation |
- Change in peak oxygen consumption (from baseline to post-study drug testing) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 53 |
| Study Start Date: | June 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin C
High-dose Vitamin C in 4 age-based doses will be given in two-daily doses for four weeks
|
Drug: Vitamin C
High-dose Vitamin C will be administered in 4 age-based dosing groups
|
|
Placebo Comparator: Placebo
Placebo will be given in two-daily doses for four weeks
|
Drug: Placebo
Placebo will be administered twice daily for four weeks
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 8 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Study Director: | John R Charpie, MD | University of Michigan |
| Principal Investigator: | Bryan H Goldstein, MD | University of Michigan |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | John R. Charpie, University of Michigan Health System |
| ClinicalTrials.gov Identifier: | NCT00974025 History of Changes |
| Other Study ID Numbers: | HUM00029464 |
| Study First Received: | September 9, 2009 |
| Last Updated: | October 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Tricuspid Atresia Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Heart Valve Diseases Congenital Abnormalities Ascorbic Acid |
Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013