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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dietary supplement: n-3 PUFA | Active Comparator | n-3 polyunsaturated fatty acids from fish oil capsules of 500 mg. 2 g a day. |
|
| olive oil | Placebo Comparator | Capsules of 500 mg. 2 g a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary supplement: n-3 PUFA | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| change in number of premature atrial complexes per day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| change in other 24 hour time domain indices of heart rate variability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper M Rantanen, MD | Department of Nephrology Aalborg University Hospital | Principal Investigator |
| Jeppe H Christensen, DMSc | Department of Nephrology Aalborg University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital, Department of Nephrology | Aalborg | 9000 | Denmark |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D001145 | Arrhythmias, Cardiac |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| olive oil |
| Dietary Supplement |
|
evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.
| baseline and 3 months |
| 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 |
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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |