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Effect of omega3 on Congestive Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01227837
First received: September 13, 2010
Last updated: October 22, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention
Heart Failure Congestive
 Dietary Supplement: placebo
Dietary Supplement: omga3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • BNP level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    level of BNP in serum of patient prior and 6 months post recruitment

  • six minutes walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    ability to walk in six minutes after and before to syudy

  • echocardiographic data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study


Secondary Outcome Measures:
  • mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    any cardiac mortality in 6 months

  • hospital admission [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    any hospital admission due to cardiac problem in 6 months


Enrollment: 70
Study Start Date: October 2008
Estimated Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   3 Months to 73 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227837

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

No publications provided

Responsible Party: Dr Javad Kojuri, Shiraz University of medical sciences
ClinicalTrials.gov Identifier: NCT01227837     History of Changes
Other Study ID Numbers: 1388-2365
Study First Received: September 13, 2010
Last Updated: October 22, 2010
Health Authority: Iran: NIH

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013