Download Aalborg Universitet

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.
General rights
Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners
and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.
? Users may download and print one copy of any publication from the public portal for the purpose of private study or research.
? You may not further distribute the material or use it for any profit-making activity or commercial gain
? You may freely distribute the URL identifying the publication in the public portal ?
Take down policy
If you believe that this document breaches copyright please contact us at [email protected] providing details, and we will remove access to
the work immediately and investigate your claim.
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