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Effect of omega3 on Congestive Heart Failure

S

Shiraz University of Medical Sciences

Status

Completed

Conditions

Heart Failure Congestive

Treatments

Dietary Supplement: placebo
Dietary Supplement: omga3

Study type

Interventional

Funder types

Other

Identifiers

NCT01227837
1388-2365

Details and patient eligibility

About

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.

Full description

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

Enrollment

70 patients

Sex

All

Ages

3 months to 73 years old

Volunteers

No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

placebo
Sham Comparator group
Description:
use of placebo in control group
Treatment:
Dietary Supplement: placebo
omega 3
Experimental group
Description:
use of omega 3 2 gr/day for 6 months
Treatment:
Dietary Supplement: omga3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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