Effect of omega3 on Congestive Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure Congestive
• Interventions: Dietary Supplement: placebo; Dietary Supplement: omga3

• Registration Number: NCT01227837
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Status Verified: 2010-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-10-22
• Last Update Submitted: 2010-10-22
• Study First Posted: 2010-10-25
• Last Update Posted: 2010-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
placebo	placebo	use of placebo in control group
omega 3	omga3	use of omega 3 2 gr/day for 6 months

Primary Outcome Measures

Name	Time	Method
BNP level	6 months	level of BNP in serum of patient prior and 6 months post recruitment
six minutes walk test	6 months	ability to walk in six minutes after and before to syudy
echocardiographic data	6 months	Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study

Secondary Outcome Measures

Name	Time	Method
mortality	6 months	any cardiac mortality in 6 months
hospital admission	6 months	any hospital admission due to cardiac problem in 6 months

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of