NCT01227837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
Last Updated

October 25, 2010

Status Verified

September 1, 2010

Enrollment Period

1.2 years

First QC Date

September 13, 2010

Last Update Submit

October 22, 2010

Conditions

Heart Failure Congestive

Keywords

omega 3CRT_AICDcongestive heart failureCHF

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • mortality

    6 months

  • hospital admission

    6 months

Study Arms (2)

placebo

SHAM COMPARATOR

use of placebo in control group

Dietary Supplement: placebo

omega 3

EXPERIMENTAL

use of omega 3 2 gr/day for 6 months

Dietary Supplement: omga3

Interventions

placeboDIETARY_SUPPLEMENT

placebo given to patients

placebo
omga3DIETARY_SUPPLEMENT

use of omega 3

omega 3

Eligibility Criteria

Age3 Months - 73 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • EF\< 40%
  • sinus rhythm
  • accept randomization
  • having tri-chamber pacemaker

You may not qualify if:

  • survival less than 6 months
  • class IV heart failure
  • using drugs other than study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, 55318, Iran

Location

Related Publications (1)

  • Kojuri J, Ostovan MA, Rezaian GR, Archin Dialameh P, Zamiri N, Sharifkazemi MB, Jannati M. Effect of omega-3 on brain natriuretic peptide and echocardiographic findings in heart failure: Double-blind placebo-controlled randomized trial. J Cardiovasc Dis Res. 2013 Mar;4(1):20-4. doi: 10.1016/j.jcdr.2013.02.013. Epub 2013 Feb 27.

    PMID: 24023466DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2010

First Posted

October 25, 2010

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

October 25, 2010

Record last verified: 2010-09

Locations

IR(1)