Arrhythmias Cardiac, Kidney Failure Chronic
Conditions
Keywords
Renal Dialysis, Arrhythmias Cardiac, Death Sudden Cardiac, Fatty Acids Omega 3
Brief 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.
Interventions
DIETARY_SUPPLEMENTdietary supplement: n-3 PUFA
DIETARY_SUPPLEMENTolive oil
Sponsors
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Dialysis \> 3 months * Age \> 18 years * Signed informed consent
Exclusion criteria
* Patients who is not able to consent. * Known allergy to contents of the olive or fish oil capsules. * Remaining life expectancy \< 3 months. * Pregnancy (positive S-HCG) - test only performed in cases of doubt.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the 24 hours time domain index: standard deviation of NN-intervals (SDNN) in milliseconds (ms) | baseline and 3 months | Evaluated using 48 hours Holter ECG recordings at baseline and after 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in number of episodes with supraventricular tachycardia per day | baseline and 3 months | evaluated using 48 hours Holter ECG recordings at baseline and after 3 months. |
| change in number of premature atrial complexes per day | baseline and 3 months | evaluated using 48 hours Holter ECG recordings at baseline and after 3 months. |
| change in Lown class of premature ventricular complexes | baseline and 3 months | Evaluated using 48 hours Holter ECG recordings at baseline and after 3 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in frequency domain indices of heart rate variability | baseline and 3 months | total power (TP), Ultra low frequency (ULF), Very low frequency (VLF), low frequency (LF), high frequency (HF) and LF/HF. Evaluated using 48 hour Holter ECG recordings at baseline and after 3 months |
| change in other 24 hour time domain indices of heart rate variability | baseline and 3 months | mean NN (ms), sNN50 (counts), sNN6%(counts), SDNNi (ms), SDANN (ms), RMSSD (ms), triangle index. Evaluated using 48 hours Holter ECG recordings at baseline and after 3 months. |
Countries
Denmark
Outcome results
None listed