Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 8 - 25 |
| Updated: | 6/2/2017 |
| Start Date: | June 2009 |
| End Date: | March 2010 |
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.
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.
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.
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
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