Kidney Failure Chronic Clinical Trial
Official title:
Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis (Renal Rhythm Study II)
Background: End Stage Renal Disease (ESRD) patients have an extremely high mortality and the
leading cause of death is cardiovascular disease which accounts for 50% of all deaths. It is
estimated that about one third is due to arrhythmias. Previous studies reveal a higher risk
of various arrhythmias in dialysis patients but the prevalence is uncertain. Atrial
fibrillation is the most common arrhythmia among patients with ESRD. The arrhythmia is often
asymptomatic, but the risk of stroke increases dramatically and the annual mortality
doubles. Autonomic cardiac dysfunction is often seen in patients with ESRD, and this is
expressed by attenuated Heart Rate Variability (HRV) which is a measure of the variation in
the time interval between heart beats. Attenuated 24 hours HRV is associated with an
increased risk of sudden cardiac death in the general population and among patients with
ESRD. N-3 polyunsaturated fatty acids (PUFAs) in fish or fish oil supplements have been
shown to increase HRV and reduce the risk of various ventricular and supraventricular
arrhythmias in some but not all studies, but this effect has only been sparsely investigated
in the high risk patients with ESRD, who has a very low intake of n-3 PUFAs.
Objective: The purpose of this study is to investigate the effects of n-3 PUFA
supplementation on HRV and arrhythmias in dialysis patients.
Hypothesis: n-3 PUFA supplementation increases 24 hours HRV in dialysis patients. n-3 PUFA
supplementation reduces the level of Supraventricular tachycardia, premature atrial
complexes (PACs) and premature ventricular complexes (PVCs) in chronic dialysis patients.
Design: Randomized double-blind, placebo controlled trial
Study participants: 140 dialysis patients at Aalborg University Hospital and Vendsyssel
Hospital, Hjørring in Denmark.
Inclusion time: Summer 2014 to Fall 2015
Methods: The patients are allocated to 3 months treatment with supplements of 2 g n-3 PUFAs
or placebo (olive oil). The following data are registered at baseline and after 3 months
treatment: Demographics and medical history, Standard ECG-12, blood pressure, blood samples,
48 hours ambulatory ECG Holter recordings, Intake of n-3 PUFAs (assessed by questionnaires
and blood measurements).
Perspective: A positive result of this study might make it possible to achieve a reduction
in arrhythmias and mortality in these high risk patients by a cheap and well tolerated
nutritional supplement.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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