Effect of omega3 on Congestive Heart Failure
Primary Purpose
Heart Failure Congestive
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
placebo
omga3
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure Congestive focused on measuring omega 3, CRT_AICD, congestive heart failure, CHF
Eligibility 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
Sites / Locations
- Shiraz University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
placebo
omega 3
Arm Description
use of placebo in control group
use of omega 3 2 gr/day for 6 months
Outcomes
Primary Outcome Measures
BNP level
level of BNP in serum of patient prior and 6 months post recruitment
six minutes walk test
ability to walk in six minutes after and before to syudy
echocardiographic data
Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study
Secondary Outcome Measures
mortality
any cardiac mortality in 6 months
hospital admission
any hospital admission due to cardiac problem in 6 months
Full Information
NCT ID
NCT01227837
First Posted
September 13, 2010
Last Updated
October 22, 2010
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01227837
Brief Title
Effect of omega3 on Congestive Heart Failure
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Congestive
Keywords
omega 3, CRT_AICD, congestive heart failure, CHF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Sham Comparator
Arm Description
use of placebo in control group
Arm Title
omega 3
Arm Type
Experimental
Arm Description
use of omega 3 2 gr/day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo given to patients
Intervention Type
Dietary Supplement
Intervention Name(s)
omga3
Intervention Description
use of omega 3
Primary Outcome Measure Information:
Title
BNP level
Description
level of BNP in serum of patient prior and 6 months post recruitment
Time Frame
6 months
Title
six minutes walk test
Description
ability to walk in six minutes after and before to syudy
Time Frame
6 months
Title
echocardiographic data
Description
Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study
Time Frame
6 months
Secondary Outcome Measure Information:
Title
mortality
Description
any cardiac mortality in 6 months
Time Frame
6 months
Title
hospital admission
Description
any hospital admission due to cardiac problem in 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
73 Years
Eligibility 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
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
55318
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24023466
Citation
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.
Results Reference
derived
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Effect of omega3 on Congestive Heart Failure
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