Coronary Artery DiseasePhase 4NCT00290056
Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillator (ICD) - A Randomized Clinical Trial
A Phase 4 study testing Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA). in people with Coronary Artery Disease and Arrhythmia, run by Sheba Medical Center at 2 sites in Israel.
Trial summary
We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Arrhythmia
- What is being tested?
- Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).
- Type of treatment
- Pill or oral medicine
- How many people
- 105 participants
- Where
- 2 sitesIsrael
- Study dates
- Nov 2005to Jun 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-MI patients.
- Both single and Dual chamber ICD recipient.
- implanted more than 3 months ago.
- Agree to give written informed consent.
Who cannot join
- Less than 18 years of age.
- ICD implantation as a 'bridge' to heart transplantation.
- Stable antiarrhythmic medication over the last month prior to enrollment.
- Patients taking class I antiarrhythmic medication.
- A projected lifespan less than one year.
- Participation in another trial (during or within 90 days before the study).
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- Use of supplemental n-3 fatty acids during the last 3 months.
- Women who are pregnant and of childbearing potential who do not use adequate contraception.
- Patients known to have a history of recent drug or alcohol abuse. 10) History or current intestinal or hepatic disease.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239.
Sheba Medical Center, Heart Institute, Electrophysiology Unit
Tel HaShomer
About this study
We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.
Read the detailed description
This is a randomized, placebo-controlled, crossover, double- blind interventional study. Patients will receive 3.6 g of EPA and DHA fish oil and placebo oil for 6 months, randomly, in a crossover design, with a four month washout period between treatments.
Randomization will be stratified by ejection fraction (≤ 35% or > 35%), and the type of the index arrhythmia (VT - spontaneous or inducible by electrophysiologic study (EPS), versus other - VF, SCD, Primary prevention - MADIT II).
Ischemia severity was chosen to be evaluated by Single Photon Emission Computed Tomography (SPECT) during stress (dipyridamol infusion).
Subcutaneous adipose-tissue biopsy, a biomarker considered the gold-standard for the objective assessment of long-term habitual dietary intake of fish and marine omega-3 PUFA (EPA and DHA) will be obtain.
Compliance will be monitored by counting returned capsules or bottles and by measuring the omega-3 PUFA composition in red blood cells (RBC).
Three different types of questionnaires will be used in this trial to obtain more information as to the additional potential benefit of omega-3 PUFA supplementation:
- The newly Israeli Food Frequency Questionnaire (FFQ) will be used to examine dietary intake of other nutritional habits/patterns and its relationship to the study outcomes.
- The Hebrew language SF-36 health survey will be used to examine general health status.
- The Back questionnaires will be use to examine possible beneficial effects of fish oil supplementation on depressive symptomatology.
- Conditions
- Coronary Artery Disease, Arrhythmia
- Being tested
- Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).
- Keywords
- CHD, Arrhythmia, ICD, Omega-3 PUFA, Nutrition
- Medical subject headings
- Coronary Artery Disease, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).Drug
3.6 gram oral supplementation for 6 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
number of VT/VF episodes
Measured: continous
Secondary outcomes (3)
All-cause mortality, cardiac mortality, recurrent and myocardial infarction.
Measured: continous
Atrial arrhythmia and non-sustained ventricular arrhythmia (non-sustained VT or ventricular premature complex (PVC)) as documented by ICD memory or 24 hour ECG (Holter) recording.
Measured: 24 hours
Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging.
Measured: time of the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionNov 2009
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- David Luria, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290056
- Sponsor's protocol ID
- SHEBA-04-3494-DL-CTIL
- Status last verified
- Nov 2009
- First submitted
- 9 Feb 2006
- Last updated
- 4 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillator (ICD) - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00290056
- Acronym / sponsor ID
- SHEBA-04-3494-DL-CTIL
- Conditions
- Coronary Artery Disease, Arrhythmia
- Keywords
- CHD, Arrhythmia, ICD, Omega-3 PUFA, Nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 10 Feb 2006 (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.
We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.
Detailed description
This is a randomized, placebo-controlled, crossover, double- blind interventional study. Patients will receive 3.6 g of EPA and DHA fish oil and placebo oil for 6 months, randomly, in a crossover design, with a four month washout period between treatments.
Randomization will be stratified by ejection fraction (≤ 35% or > 35%), and the type of the index arrhythmia (VT - spontaneous or inducible by electrophysiologic study (EPS), versus other - VF, SCD, Primary prevention - MADIT II).
Ischemia severity was chosen to be evaluated by Single Photon Emission Computed Tomography (SPECT) during stress (dipyridamol infusion).
Subcutaneous adipose-tissue biopsy, a biomarker considered the gold-standard for the objective assessment of long-term habitual dietary intake of fish and marine omega-3 PUFA (EPA and DHA) will be obtain.
Compliance will be monitored by counting returned capsules or bottles and by measuring the omega-3 PUFA composition in red blood cells (RBC).
Three different types of questionnaires will be used in this trial to obtain more information as to the additional potential benefit of omega-3 PUFA supplementation:
- The newly Israeli Food Frequency Questionnaire (FFQ) will be used to examine dietary intake of other nutritional habits/patterns and its relationship to the study outcomes.
- The Hebrew language SF-36 health survey will be used to examine general health status.
- The Back questionnaires will be use to examine possible beneficial effects of fish oil supplementation on depressive symptomatology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- post-MI patients.
- Both single and Dual chamber ICD recipient.
- implanted more than 3 months ago.
- Agree to give written informed consent.
Key exclusion criteria (9 listed)
- Less than 18 years of age.
- ICD implantation as a 'bridge' to heart transplantation.
- Stable antiarrhythmic medication over the last month prior to enrollment.
- Patients taking class I antiarrhythmic medication.
- A projected lifespan less than one year.
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 |
|---|---|---|
| Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).3.6 gram oral supplementation for 6 months. | Drug | – |
Primary outcome
number of VT/VF episodes
Time frame: continous
3 secondary outcomes
All-cause mortality, cardiac mortality, recurrent and myocardial infarction.
Time frame: continous
Atrial arrhythmia and non-sustained ventricular arrhythmia (non-sustained VT or ventricular premature complex (PVC)) as documented by ICD memory or 24 hour ECG (Holter) recording.
Time frame: 24 hours
Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging.
Time frame: time of the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
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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.
David Luria, MD principal investigator
Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA). in people with Coronary Artery Disease and Arrhythmia, run by Sheba Medical Center at 2 sites in Israel.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
number of VT/VF episodes (time frame: continous). 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 4 Nov 2009.