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OpenTrials
Completed

NCT Number: NCT01227837

Effect of omega3 on Congestive Heart Failure

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.

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Key information

Age range

3 month–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shiraz University of Medical Sciences

Shiraz, Fars, 55318, Iran

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

placebo given to patients

omga3

Dietary Supplement

use of omega 3

Primary outcomes

  1. BNP level

    Time frame: 6 months

    level of BNP in serum of patient prior and 6 months post recruitment

  2. six minutes walk test

    Time frame: 6 months

    ability to walk in six minutes after and before to syudy

  3. echocardiographic data

    Time frame: 6 months

    Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study

Secondary outcomes

  1. mortality

    Time frame: 6 months

    any cardiac mortality in 6 months

  2. hospital admission

    Time frame: 6 months

    any hospital admission due to cardiac problem in 6 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 25, 2010
Registry last updated
Oct 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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