Effect of omega3 on Congestive Heart Failure

Heart Failure Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227837
• Other study ID #: 1388-2365
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: October 22, 2010
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: September 2010
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: NIH
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Gender: Both
• Age group: 3 Months to 73 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Congestive

Intervention

Dietary Supplement:
• placebo
placebo given to patients
• omga3
use of omega 3

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BNP level	level of BNP in serum of patient prior and 6 months post recruitment	6 months	No
Primary	six minutes walk test	ability to walk in six minutes after and before to syudy	6 months	No
Primary	echocardiographic data	Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study	6 months	No
Secondary	mortality	any cardiac mortality in 6 months	6 months	Yes
Secondary	hospital admission	any hospital admission due to cardiac problem in 6 months	6 months	Yes