Kidney Failure ChronicNCT02147977
Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis
A study testing dietary supplement: n-3 PUFA and olive oil in people with Kidney Failure Chronic and Arrhythmias Cardiac, run by Aalborg University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Failure Chronic, Arrhythmias Cardiac
- What is being tested?
- dietary supplement: n-3 PUFA and olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis > 3 months
- Age > 18 years
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University Hospital, Department of Nephrology
Aalborg, 9000
About this study
Official title: Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis (Renal Rhythm Study II)
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.
Read more
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.
- Conditions
- Kidney Failure Chronic, Arrhythmias Cardiac
- Being tested
- dietary supplement: n-3 PUFA, olive oil
- Keywords
- Renal Dialysis, Arrhythmias Cardiac, Death Sudden Cardiac, Fatty Acids Omega 3
- Medical subject headings
- Renal Insufficiency, Chronic, Arrhythmias, Cardiac, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement: n-3 PUFADietary supplement
Also called Calamarine 250/250 TG
olive oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| dietary supplement: n-3 PUFA | Active comparator | n-3 polyunsaturated fatty acids from fish oil
capsules of 500 mg. 2 g a day. Receives: Dietary Supplement: dietary supplement: n-3 PUFA |
| olive oil | Placebo comparator | Capsules of 500 mg. 2 g a day. Receives: Dietary Supplement: olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 months
Secondary outcomes (3)
change in number of episodes with supraventricular tachycardia per day
evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.
Measured: baseline and 3 months
change in number of premature atrial complexes per day
evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.
Measured: 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.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure ChronicStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Moesgaard Rantanen, Aalborg University Hospital
- Investigators
- Jesper M Rantanen, MD, Principal investigator, Department of Nephrology Aalborg University HospitalJeppe H Christensen, DMSc, Study director, Department of Nephrology Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147977
- Sponsor's protocol ID
- N-20140013
- Status last verified
- Jul 2016
- First submitted
- 21 May 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis (Renal Rhythm Study II)
- ClinicalTrials.gov ID
- NCT02147977
- Acronym / sponsor ID
- N-20140013
- Conditions
- Kidney Failure Chronic, Arrhythmias Cardiac
- Keywords
- Renal Dialysis, Arrhythmias Cardiac, Death Sudden Cardiac, Fatty Acids Omega 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary supplement: n-3 PUFA | Active comparator | Dietary Supplement: dietary supplement: n-3 PUFAn-3 polyunsaturated fatty acids from fish oil capsules of 500 mg. 2 g a day. |
| olive oil | Placebo comparator | Dietary Supplement: olive oilCapsules of 500 mg. 2 g a day. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dialysis > 3 months
- Age > 18 years
- Signed informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary supplement: n-3 PUFAAlso: Calamarine 250/250 TG | Dietary supplement | dietary supplement: n-3 PUFA |
| olive oil | Dietary supplement | olive oil |
Primary outcome
Change in the 24 hours time domain index: standard deviation of NN-intervals (SDNN) in milliseconds (ms)
Time frame: baseline and 3 months
Evaluated using 48 hours Holter ECG recordings at baseline and after 3 months.
3 secondary outcomes
change in number of episodes with supraventricular tachycardia per day
Time frame: baseline and 3 months
change in number of premature atrial complexes per day
Time frame: baseline and 3 months
change in Lown class of premature ventricular complexes
Time frame: baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper M Rantanen, MD principal investigator
Department of Nephrology Aalborg University Hospital
Jeppe H Christensen, DMSc study director
Department of Nephrology Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement: n-3 PUFA and olive oil in people with Kidney Failure Chronic and Arrhythmias Cardiac, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 24 hours time domain index: standard deviation of NN-intervals (SDNN) in milliseconds (ms) (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.