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
Protocol serial number	S1853001
Sponsor	Solvay Pharmaceuticals GmbH (Germany)
Funder	Solvay Pharmaceuticals GmbH (Germany)

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

Dr Cornel Pater
Scientific

An der Trift 18
Hannover
30559
Germany

Phone	+49 (0)511 857 2074
Email	cornel.pater@solvay.com

Primary study design	Interventional
Study design	A randomised, parallel group, double-blind, placebo-controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Omacor
Primary outcome measure(s)	Superiority of Omacor to improve HRV from baseline to endpoint.
Key secondary outcome measure(s)	1. Improvement in time domain HRV indices 2. Safety
Completion date	01/01/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

An der Trift 18

Hannover
30559
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	15/10/2003		Yes	No