Clinical trial NCT01227837: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Congestive
Keywords: omega 3
CRT_AICD
congestive heart failure
CHF
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: BNP level
timeFrame: 6 months
measure: six minutes walk test
timeFrame: 6 months
measure: echocardiographic data
timeFrame: 6 months
Secondary outcomes:
measure: mortality
timeFrame: 6 months
measure: hospital admission
timeFrame: 6 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
References:
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.