Renal Failure, ChronicPhase 2NCT00259025
Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients
A Phase 2 study testing lipid emulsion with a high content of n-3 fatty acids in people with Renal Failure, Chronic, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Failure, Chronic
- What is being tested?
- lipid emulsion with a high content of n-3 fatty acids
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Jul 2007
- Phase
- Phase 2
- 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
- Age > 18 yrs
- End-stage renal failure
- Maintenance haemodialysis treatment > 3 months
Who cannot join
- Allergy to fish or egg protein
- Body weight < 50 kgs
- Chronic supraventricular tachycardia
- Implanted pacemaker
- Myocardial infarction within 6 months
- PCI or CABG within 6 months
Show all 15Show fewer
- Stroke or TIA within 6 months
- HbA1C > 10 %
- ALAT > 100 U/l
- Triglycerides > 3 mmol/l
- Ongoing infection
- Tendency to severe blood pressure drops during dialysis treatment
- Malignancy
- Psychiatric disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients
The main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients.
Read the detailed description
Cardiovascular disease is the most common cause of death in haemodialysis (HD)patients, and half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. HD patients have an attenuated heart rate variability (HRV) and a high frequency of ventricular arrhythmias, both of which are predictors of sudden cardiac death(SCD). n-3 polyunsaturated fatty acids (PUFA) improves HRV and reduces the risk of SCD. n-3 PUFAs are obtained from fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion. However, it is not known if this incorporation is essential or merely serves as storage for n-3 free PUFAs to be release during for instance myocardial ischaemia.
The study hypothesis is that intravenous infusion of a lipid emulsion with a high content of n-3 PUFAs will improve HRV and ventricular repolarization and reduce ventricular arrhythmias via an acute increase in free non-esterified n-3 PUFAs in plasma.
In a randomized, placebo-controlled design a n-3 PUFA rich emulsion (or placebo) will be administered during hemodialysis treatment. The two study groups will be compared with respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic beats and arrhythmias and the content of n-3 PUFA in plasma and cell membranes will be compared.
- Conditions
- Renal Failure, Chronic
- Being tested
- lipid emulsion with a high content of n-3 fatty acids
- Keywords
- Renal failure, chronic, Death, sudden, cardiac, Heart rate variability, Tachycardia, ventricular, Ventricular premature complexes, Ventricular repolarization, Eicosapentaenoic acid, Docosahexaenoic acid
- Medical subject headings
- Kidney Failure, Chronic, Death, Sudden, Cardiac, Tachycardia, Ventricular, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid emulsion with a high content of n-3 fatty acidsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Secondary outcomes (2)
Ventricular repolarization, ventricular arrhythmias
n-3 polyunsaturated fatty acids in plasma and cell membranes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startSep 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jeppe H Christensen, MD, DMSci, Principal investigator, Aalborg Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259025
- Sponsor's protocol ID
- IVN3DIALYSE
- Status last verified
- Apr 2008
- First submitted
- 25 Nov 2005
- Last updated
- 11 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00259025
- Acronym / sponsor ID
- IVN3DIALYSE
- Conditions
- Renal Failure, Chronic
- Keywords
- Renal failure, chronic, Death, sudden, cardiac, Heart rate variability, Tachycardia, ventricular, Ventricular premature complexes, Ventricular repolarization, Eicosapentaenoic acid, Docosahexaenoic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Nov 2005 (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.
The main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients.
Detailed description
Cardiovascular disease is the most common cause of death in haemodialysis (HD)patients, and half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. HD patients have an attenuated heart rate variability (HRV) and a high frequency of ventricular arrhythmias, both of which are predictors of sudden cardiac death(SCD). n-3 polyunsaturated fatty acids (PUFA) improves HRV and reduces the risk of SCD. n-3 PUFAs are obtained from fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion. However, it is not known if this incorporation is essential or merely serves as storage for n-3 free PUFAs to be release during for instance myocardial ischaemia.
The study hypothesis is that intravenous infusion of a lipid emulsion with a high content of n-3 PUFAs will improve HRV and ventricular repolarization and reduce ventricular arrhythmias via an acute increase in free non-esterified n-3 PUFAs in plasma.
In a randomized, placebo-controlled design a n-3 PUFA rich emulsion (or placebo) will be administered during hemodialysis treatment. The two study groups will be compared with respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic beats and arrhythmias and the content of n-3 PUFA in plasma and cell membranes will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 yrs
- End-stage renal failure
- Maintenance haemodialysis treatment > 3 months
Key exclusion criteria (15 listed)
- Allergy to fish or egg protein
- Body weight < 50 kgs
- Chronic supraventricular tachycardia
- Implanted pacemaker
- Myocardial infarction within 6 months
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 |
|---|---|---|
| lipid emulsion with a high content of n-3 fatty acids | Drug | – |
Primary outcome
Heart rate variability
2 secondary outcomes
Ventricular repolarization, ventricular arrhythmias
n-3 polyunsaturated fatty acids in plasma and cell membranes
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 11 Aug 2008.
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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.
Jeppe H Christensen, MD, DMSci principal investigator
Aalborg Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lipid emulsion with a high content of n-3 fatty acids in people with Renal Failure, Chronic, 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 15 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 11 Aug 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Heart rate variability. 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 11 Aug 2008.