Heart Failure Congestive
Conditions
Keywords
omega 3, CRT_AICD, congestive heart failure, CHF
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
Interventions
DIETARY_SUPPLEMENTplacebo
placebo given to patients
DIETARY_SUPPLEMENTomga3
use of omega 3
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 73 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| mortality | 6 months | any cardiac mortality in 6 months |
| hospital admission | 6 months | any hospital admission due to cardiac problem in 6 months |
Countries
Iran
Outcome results
None listed