Heart Failure Clinical Trial
— OMEMIOfficial title:
Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Verified date | August 2020 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the present study is to investigate the possible effects of supplementation with
1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during
a follow-up period of 2 years in an elderly population after having experienced an acute
myocardial infarction.
The hypothesis is that this supplementation on top of modern therapy will reduce the combined
cardiovascular end-point of death, non-fatal myocardial infarction, stroke,
revascularizations or hospitalization for new or worsened heart failure with at least 30%.
Status | Completed |
Enrollment | 1027 |
Est. completion date | June 26, 2020 |
Est. primary completion date | June 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years to 82 Years |
Eligibility |
Inclusion Criteria: - Patients with acute myocardial infarction discharged from hospital alive Exclusion Criteria: - Being part of another randomized trial - Documented intolerance for omega-3 fatty acids - Additional disease state that is thought to be incompatible with compliance to the study drugs - Additional disease state thought to reduce survival for the follow-up time of 2 years |
Country | Name | City | State |
---|---|---|---|
Norway | Akershus university hospital HF | Lørenskog | |
Norway | Oslo University Hospital(Ullevaal) | Oslo | |
Norway | Asker and Bærum Hospital | Rud | Bærum |
Norway | Stavanger University Hospital | Stavanger |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Asker & Baerum Hospital, Helse Stavanger HF, University Hospital, Akershus |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. | 24months | ||
Secondary | Occurence of new onset atrial fibrillation | 24months |
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