Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis
Condition: Kidney Failure Chronic; Arrhythmias Cardiac
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): dietary supplement: n-3 PUFA; olive oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Calamarine 250/250 TG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Renal Dialysis; Arrhythmias Cardiac; Death Sudden Cardiac; Fatty Acids Omega 3