Aalborg University Hospital, Department of Nephrology
Aalborg, 9000, Denmark
NCT Number: NCT02147977
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.
Looking for future studies?
Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Aalborg, 9000, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Calamarine 250/250 TG
Time frame: baseline and 3 months
Evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.
Time frame: baseline and 3 months
evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.
Time frame: baseline and 3 months
evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.
Time frame: baseline and 3 months
Evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.
Time frame: 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
Time frame: 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.
Aalborg University Hospital
Other
Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis (Renal Rhythm Study II)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07612124
Chronic Disease, Disease Attributes
Changsha, Hunan, China
View Trial DetailsNCT07730385
Cardiovascular Disease, Cardiovascular Diseases
Vienna, State of Vienna, Austria
View Trial DetailsNCT07544797
Chronic Disease, Disease Attributes
Halle, Saxony-Anhalt, Germany
View Trial DetailsNCT06910475
Behavior, Chronic Disease
Taguatinga, Federal District, Brazil
View Trial Details