Cardiovascular Disease Clinical Trial
Official title:
Vitamin D Supplementation and Cardiac Autonomic Tone in Hemodialysis Patients: A Blinded, Randomized-controlled Trial
Despite advances in treatment of conventional cardiovascular risk factors, patients with
kidney disease remain at high risk for fatal cardiac events. To date, kidney disease affects
approximately 2 million Canadians; however, this patient population remains grossly
understudied due to the complex nature of the disease. The inadequacy of the literature to
address the cardiovascular-related mortality rates in those with kidney disease reflects the
urgent need for investigation of novel risk factors.
One cardiovascular risk factor which has recently been validated is the clinical measurement
of cardiac autonomic tone (CAT). CAT refers to the amount of activity contributed by the
stimulatory and inhibitory limbs of the cardiac autonomic nervous system, which work in
concert with one another to control heart rate. CAT can be quantified computer analysis of
heart rate over time, captured by a simple Holter electrocardiogram (ECG) recording.
Abnormal CAT, which occurs when the autonomic system does not control heart rate properly in
response to physical demands or stress, is associated with risk of adverse cardiovascular
events in both healthy and high risk populations. It has recently been shown that patients
with severe kidney disease demonstrate significant CAT abnormalities, thus exaggerated
susceptibility to cardiac death.
Vitamin D (VD) deficiency is also common in this patient population due to the fact that the
kidney plays a crucial role in VD metabolism. Given that VD deficiency is an established
cardiovascular risk factor on its own, it is possible that kidney disease patients
experienced compounded risk due to the combination of VD deficiency and abnormal CAT.
However, no study has ever investigated whether VD deficiency influences CAT in healthy or
diseased populations. To our knowledge, this will be the first trial to ever examine the
effect, if any, of different VD supplementation treatments (standard of care vs.
combination) on CAT in a population burdened with overwhelming risk and incidence of
cardiovascular and sudden cardiac death risk.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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