Effect of omega3 on Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01227837
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Information provided by:
Shiraz University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment
Heart Failure Congestive Dietary Supplement: placebo Dietary Supplement: omga3

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Omega 3 Supplementation on Brain Natriuretic Peptide (BNP) Serum Levels Functional Capacity and Systolic and Diastolic Function of Heart Failure Patients
Study Start Date : October 2008
Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: placebo
use of placebo in control group
Dietary Supplement: placebo
placebo given to patients
Experimental: omega 3
use of omega 3 2 gr/day for 6 months
Dietary Supplement: omga3
use of omega 3

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   3 Months to 73 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01227837

Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of, 55318
Sponsors and Collaborators
Shiraz University of Medical Sciences

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Javad Kojuri, Shiraz University of medical sciences Identifier: NCT01227837     History of Changes
Other Study ID Numbers: 1388-2365
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: September 2010

Keywords provided by Shiraz University of Medical Sciences:
omega 3
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases