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Aalborg Universitet Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis (Renal Rhythm Stdy II) - Rationale and Design Rantanen, Jesper Moesgaard; Pedersen, Birgitte Bang; Riahi, Sam; Schmidt, Erik Berg; Christensen, Jeppe Hagstrup Publication date: 2014 Document Version Early version, also known as pre-print Link to publication from Aalborg University Citation for published version (APA): Rantanen, J. M., Pedersen, B. B., Riahi, S., Schmidt, E. B., & Christensen, J. H. (2014). Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis (Renal Rhythm Stdy II) - Rationale and Design. Poster session presented at The Healthy Researc, Aalborg, Denmark. 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Downloaded from vbn.aau.dk on: September 17, 2016 Effects of Marine n n-3 3 Fatty y Acids on Heart Rate Variability y and Arrhythmias y in Patients Receiving g Chronic Dialysis y (R (Renal l Rhythm Rh th Study St d II) – Rationale R ti l and d Design D i Rantanen JM 1, Pedersen BB 1, Riahi S 2, Schmidt EB 2, Christensen JH 1 1.Department 1 Department of Nephrolog Nephrology, Centre for Cardio Cardiovascular asc lar Research Research, Aalborg Uni University ersit Hospital Hospital, Aalborg Aalborg, Denmark 2 Department of Cardiology 2. Cardiology, Centre for Cardiovascular Research, Research AF Study Group, Group Aalborg University Hospital, Hospital Aalborg, Aalborg Denmark Introduction I t d ti End Stage Renal Disease (ESRD) patients have an extremely high mortality. mortality Fifty percent of all deaths are cardiovascular di l related l t d and d manyy due d to t cardiac di arrhythmias arrhythmias. A high p off various arrhythmias p t d in high prevalence l i hyth i are reported i dialysis patients patients. Atrial fibrillation (AF) is the most common arrhythmia and often asymptomatic asymptomatic, but can be symptomatic y pt ti especially p i lly d during i g th the di dialysis ly i ttreatment. t t Furthermore , the risk of stroke increases dramatically and the mortality doubles Autonomic cardiac dysfunction is often seen in patients with ESRD ESRD, and this is expressed by attenuated Heart Rate V i bility (HRV) Variability ( ) which hi h iis a measure off the th variation i ti in i the th time interval between heartbeats. heartbeats Attenuated 24 hours HRV is associated with an increased risk of sudden cardiac death d th iin the th general g l population p p l ti and d among g ESRD patients. p ti t Design Randomized placebo R d i dp l b controlled t ll d trial. ti l Screening Patients are allocated to 3 months t t treatment t with ith supplements ppl t off 2 g n-3 3 PUFAs (Calamarine® 250/250TG) or placebo (olive oil) to examine the ff t on HRV and d arrhythmias hyth i effects recorded by 48 hours ambulatory monitoring ECG Holter monitoring. Inclusion n=140 Study population Chronic dialysis Aalborg Ch i di ly i patients p ti t att A lb g University Hospital and Vendsyssel Hospital Hjørring Hospital, Hjørring, Denmark Denmark. S pl size Sample i n=140. 140 n-3 Marine n 3 polyunsaturated fatty acids (PUFAs) have been shown h tto increase i HRV and d reduce d th the risk i k off various i arrhythmias This effect has only been sparsely arrhythmias. investigated in the high risk patients with ESRD who has a l low intake i t k off n-3 3 PUFAs. PUFA Visit 1 Randomization Visit 2 n 3 PUFA n-3 n= 70 Visit 2 Pl b Placebo n=70 Visit 3 Visit 3 Visit 4 Visit 4 Study Procedures Hypothesis n-3 3 PUFA supplementation ppl t ti increases i 24 hours h HRV in i chronic dialysis patients. patients n-3 n 3 PUFA supplementation reduces the level of supraventricular p t i l tachycardia t hy di (SVTs), (SVT ( ), ) premature p t atrial ti l complexes (PACs) and premature ventricular complexes (PVCs) in chronic dialysis patients. patients Visit 1 Visit 2 Visit 3 Visit 4 (day 1) (day 3) (day 95) (day 97) Start Holter Monitoring g End Holter Monitoring g Start Holter Monitoring g End Holter Monitoring g ECG CG ECG CG Blood samples Blood samples Blood p pressure Blood p pressure Interview Interview Randomization Begin g Investigational est gat o a Product End Investigational est gat o a Product Aims Th p The purpose p off this thi study t dy is i to t investigate i tig t the th effects ff t off n-3 3 PUFA supplementation on HRV and arrhythmias in patients with ESRD. Primary endpoint • 24 hours HRV – SDNN (standard deviation of NN intervals) Secondary endpoints • Other HRV indices • AF and d SVTs SVT • Number of PACs • Number of PVCs and Lown classification Perspective If we are able to demonstrate a significant effect of n n-3 3 PUFAs one might achieve a reduction in the risk of arrhythmias and by that possibly poss ibl b y reduce educe d morbidity ob bidi d ty a and d mortality o tality iin tthis his high high risk isk population populatio by b a cheap and well tolerated nutritional supplement. supplement