Acute Heart FailurePhase 4NCT00692718
N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure
A Phase 4 study testing Epadel, Eicosapentaenoic acid in people with Acute Heart Failure and Acute Myocardial Infarction, run by Osaka General Medical Center.
Trial summary
Our study is to investigate the effect of N-3 Fatty Acids for the prevention of atrial fibrillation in patients with acute heart failure or acute myocardial infarction Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Heart Failure, Acute Myocardial Infarction
- What is being tested?
- Epadel, Eicosapentaenoic acid
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sinus rhythm patients with acute heart failure or acute myocardial infarction
Who cannot join
- pregnancy,allergy to epadel
About this study
Our study is to investigate the effect of N-3 Fatty Acids for the prevention of atrial fibrillation in patients with acute heart failure or acute myocardial infarction
- Conditions
- Acute Heart Failure, Acute Myocardial Infarction
- Being tested
- Epadel, Eicosapentaenoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epadel, Eicosapentaenoic acidDrug
Epadel 900mg, 2 times a day, during hospitalization
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of atrial fibrillation on ECG monitoring
Measured: anytime during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka General Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692718
- Sponsor's protocol ID
- OFAHeft
- Status last verified
- Jun 2008
- First submitted
- 29 May 2008
- Last updated
- 19 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT00692718
- Acronym / sponsor ID
- OFAHeft
- Conditions
- Acute Heart Failure, Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Osaka General Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (estimated)
- First posted
- 6 Jun 2008 (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.
Our study is to investigate the effect of N-3 Fatty Acids for the prevention of atrial fibrillation in patients with acute heart failure or acute myocardial infarction
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sinus rhythm patients with acute heart failure or acute myocardial infarction
Key exclusion criteria (1 listed)
- pregnancy,allergy to epadel
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 |
|---|---|---|
| Epadel, Eicosapentaenoic acidEpadel 900mg, 2 times a day, during hospitalization | Drug | – |
Primary outcome
detection of atrial fibrillation on ECG monitoring
Time frame: anytime during hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epadel, Eicosapentaenoic acid in people with Acute Heart Failure and Acute Myocardial Infarction, run by Osaka General Medical Center.
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 1 inclusion and 1 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 19 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
detection of atrial fibrillation on ECG monitoring (time frame: anytime during hospitalization). 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 19 Jun 2008.