Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147977
• Other study ID #: N-20140013
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: July 26, 2016
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmias Cardiac
• Kidney Failure Chronic
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Dietary Supplement:
• dietary supplement: n-3 PUFA

• olive oil

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital, Department of Nephrology	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in frequency domain indices of heart rate variability	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	baseline and 3 months	No
Other	change in other 24 hour time domain indices of heart rate variability	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.	baseline and 3 months	No
Primary	Change in the 24 hours time domain index: standard deviation of NN-intervals (SDNN) in milliseconds (ms)	Evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.	baseline and 3 months	No
Secondary	change in number of episodes with supraventricular tachycardia per day	evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.	baseline and 3 months	No
Secondary	change in number of premature atrial complexes per day	evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.	baseline and 3 months	No
Secondary	change in Lown class of premature ventricular complexes	Evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.	baseline and 3 months	No