Effect of omacor on heart rate variability (HRV) parameters in patients with recent uncomplicated myocardial infarction
| ISRCTN | ISRCTN75358739 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75358739 |
| Secondary identifying numbers | S1853001 |
- Submission date
- 13/10/2003
- Registration date
- 13/10/2003
- Last edited
- 08/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Cornel Pater
Scientific
Scientific
An der Trift 18
Hannover
30559
Germany
| Phone | +49 (0)511 857 2074 |
|---|---|
| cornel.pater@solvay.com |
Study information
| Study design | A randomised, parallel group, double-blind, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate the effect of Omacor on time-domain heart rate variability (HRV) parameters in comparison to placebo in patients with recent uncomplicated transmural myocardial infarction. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Myocardial infarction |
| Intervention | Based on the inclusion criteria, a first 24-hour Holter recording will be performed. Two to five days later, screened patients still eligible for the study will undergo a second 24-hour Holter recording. After the second Holter recording, all patients will be randomly allocated to treatment with Omacor 1 g once daily (o.d.) or placebo o.d. Patients will be followed-up in double-blind fashion for a six-month period after randomisation. Visits, including 24-hour Holter recording and assessment of adverse events, will take place at one-month intervals ± five days after randomisation, i.e., six times in all. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Omacor |
| Primary outcome measure | Superiority of Omacor to improve HRV from baseline to endpoint. |
| Secondary outcome measures | 1. Improvement in time domain HRV indices 2. Safety |
| Overall study start date | 01/01/2004 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Males and females aged 40 years or older 2. Recent sustained acute myocardial infarction (AMI) 3. Women of childbearing age are subject to pregnancy testing and must agree to maintain adequate hormonal contraception 4. Signed informed consent |
| Key exclusion criteria | 1. Clinically or hemodynamically unstable condition 2. Further invasive investigation, a percutaneous transluminal coronary angioplasty (PTCA) or a coronary atrery bypass graft (CABG) are required 3. Sustained antiarrhythmic therapy (other than a beta-blocking agent administered in the context of secondary prevention of MI) 4. Severe concomitant illness (related to any body organ or system) that is likely to affect outcome assessment 5. Compliance problems 6. Participating in another trial within the past 30 days 7. Pregnant or lactating 8. Known hypersensitivity to the ingredients in Omacor or intolerability to olive oil 9. Diabetes mellitus type I and II |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Germany
- Lithuania
- Poland
Study participating centre
An der Trift 18
Hannover
30559
Germany
30559
Germany
Sponsor information
Solvay Pharmaceuticals GmbH (Germany)
Industry
Industry
Hans-Boeckler Alee 20
Hannover
30173
Germany
"ROR" |
https://ror.org/01xscrc43 |
|---|
Funders
Funder type
Industry
Solvay Pharmaceuticals GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 15/10/2003 | Yes | No |
