Effect of omega3 on Congestive Heart Failure

Study Overview
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Brief Summary
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In this double blinded study patients with resynchronization pacemaker- AICD were assigned to Omega3 and placebo randomly, results indicated that Omega3 had no more effect than placebo in mortality, BNP level and 6 minutes walk test.

Detailed Description
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Introduction: Widely used as lipid lowering agents, Omega 3 fatty acids have been demonstrated to possess the potential to reduce the risk of cardiovascular events in patients suffering from chronic heart conditions. In this double -blinded randomized placebo-controlled clinical trial, we aim to investigate the possible beneficial effects of Omega-3 supplements on echocardiographic parameters and brain natriuretic peptide (BNP) plasma levels in patients suffering from congestive heart failure (CHF). Methods and Materials: 100 patients with class II and III CHF, who had tri-chamber pacemaker and automated defibrillator( CRT-AICD) were initially recruited among which 70 subjects consented to participate. Subjects were randomly assigned and matched to two treatment groups. 42 patients were allocated to a two gram/day dosing of omega-3 capsule while 28 subjects were allocated to the placebo group. Demographic features and BNP plasma levels, 6-minute walk test and echocardiographic parameters of patients were recorded at baseline and at 6 months after implementation of treatment protocols. Data were further gathered and analyzed to evaluate the beneficial effects of omega-3 supplements compared to placebo. Conclusion: Beneficial effects of Omega-3 supplementation on CHF patients were not as dramatic as initially presumed

Official Title
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Effect of Omega 3 Supplementation on Brain Natriuretic Peptide (BNP) Serum Levels Functional Capacity and Systolic and Diastolic Function of Heart Failure Patients

Conditions
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Heart Failure Congestive

Intervention / Treatment
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* Dietary Supplement: placebo
* Dietary Supplement: omga3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EF< 40% sinus rhythm accept randomization having tri-chamber pacemaker Exclusion criteria: survival less than 6 months class IV heart failure using drugs other than study protocol

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: placebo<br>use of placebo in control group | Dietary Supplement: placebo<br>* placebo given to patients<br>|
| Experimental: omega 3<br>use of omega 3 2 gr/day for 6 months | Dietary Supplement: omga3<br>* use of omega 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BNP level | level of BNP in serum of patient prior and 6 months post recruitment | 6 months | 
| six minutes walk test | ability to walk in six minutes after and before to syudy | 6 months | 
| echocardiographic data | Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | any cardiac mortality in 6 months | 6 months | 
| hospital admission | any hospital admission due to cardiac problem in 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega 3, CRT_AICD, congestive heart failure, CHF