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The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LOVAZA (Omega-3)
Placebo
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, omega 3, lovaza, VO2 max

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All subjects with CHF due to systolic dysfunction followed at the outpatient facilities of Columbia University Medical Center will be screened and subjects will be asked to participate if the following criteria are met:

  • Older than 18 years.
  • Symptomatic heart failure (New York Heart Association functional class II-III).
  • Ischemic or non-ischemic cardiomyopathy.
  • Left ventricular ejection fraction (EF) 40% or lower.
  • Peak oxygen uptake (VO2, peak) between 10 and 17 mL O2/min/kg.
  • Be on appropriate, stable medical treatments for heart failure, including (unless shown to be intolerant) a diuretic, an angiotensin-converting enzyme inhibitor and/or angiotensin-receptor blocker and a beta-blocker, pacemaker or ICD or CRT.

Exclusion Criteria:

  • Unable to perform treadmill exercise
  • Pregnancy
  • Recent myocardial infarction (within 3 months).
  • Clinically significant angina.
  • Hospitalization for heart failure requiring intravenous treatments within 30 days.
  • Allergy to fish

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 Drug Treatment - LOVAZA

2 placebo

Arm Description

Drug Treatment - LOVAZA 4 gm q24 for 8 weeks

Placebo 4 capsules q24 for 8 weeks

Outcomes

Primary Outcome Measures

Change in Peak VO2
Change in Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) After 8 Weeks of Omega 3 Supplementation.
Change in Base Line Oxidized Low Density Lipoprotein (LDL) Level and in Response to Exercise

Secondary Outcome Measures

Full Information

First Posted
February 12, 2009
Last Updated
April 26, 2016
Sponsor
Columbia University
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00944229
Brief Title
The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure
Official Title
Salutary Effects of Dietary Supplementation With OMEGA 3 on Exercise Performance and Endothelial Function in Patients With Congestive Heart Failure. A Matter of Lipid Oxidation ?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
PI left the institution
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A diet rich in Omega-3 (fish oil) reduces plasma triglycerides and the risk for ischemic heart disease. Recently, a large trial evaluating treatment with Omega 3 in heart failure patients suggested that omega 3 may lower the risk of death from CHF. The mechanism of this potential benefit is not well understood. Methods: Forty patients will be enrolled in the study. Twenty patients will receive Omega 3 (lovaza 4 gm a day) and 20 patients will receive placebo. All subjects will have assessment of their exercise capacity and blood vessel function before and after an 8 week treatment period. About 4 table spoons of blood will be drawn throughout the study. Expected results: The investigators believe that omega 3 may improve the ability to exercise and improve blood vessel function.
Detailed Description
A diet rich in Omega-3 polyunsaturated fatty acids Omega 3 reduces plasma triglycerides and the risk for ischemic heart disease1, and may exert direct antiarrhythmic effect on the myocardium 2-9. A post-hoc analysis of the GISSI-Prevenzione trial demonstrated a reduction in all-cause and sudden mortality in a subgroup of nearly 2000 post-infarction patients with left ventricular dysfunction 10. This provocative finding has now been prospectively studied in a large-scale, randomized, double-blind study designed to investigate the effects of Omega 3 on mortality and morbidity in patients with symptomatic heart failure (the GISSI Heart Failure project). The results of the GISSI-HF trial demonstrate that 1 g per day of Omega 3 is associated with 9% reduction in mortality and cardiovascular admissions in patients with predominantly systolic heart failure, when added to optimal medical therapy11. The mechanism(s) underlying these beneficial effects remains to be elucidated and will be critical in fully exhausting the therapeutic benefits of Omega 3 in CHF. We have recently demonstrated that lipid oxidation during acute exercise is altered in patients with CHF 12 and that the degree of this alteration carries prognostic significance. It is conceivable that Omega 3 modulates lipid oxidation during exercise and thereby favorably effect outcome. Accordingly we propose to study the effect of Omega 3 on lipid oxidation during exercise in CHF. We will further examine VO2 and endothelial function at present the principal surrogate markers for survival in CHF 13.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, omega 3, lovaza, VO2 max

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Drug Treatment - LOVAZA
Arm Type
Active Comparator
Arm Description
Drug Treatment - LOVAZA 4 gm q24 for 8 weeks
Arm Title
2 placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 4 capsules q24 for 8 weeks
Intervention Type
Drug
Intervention Name(s)
LOVAZA (Omega-3)
Intervention Description
LOVAZA 4 gm q24 for 8 weeks Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 capsules of placebo every 24 hours
Primary Outcome Measure Information:
Title
Change in Peak VO2
Time Frame
0, 1 and 8 weeks of Omega 3 supplementation.
Title
Change in Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) After 8 Weeks of Omega 3 Supplementation.
Time Frame
0 and after 8 weeks of Omega 3 supplementation.
Title
Change in Base Line Oxidized Low Density Lipoprotein (LDL) Level and in Response to Exercise
Time Frame
0, 1 and 8 weeks of Omega 3 supplementation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects with CHF due to systolic dysfunction followed at the outpatient facilities of Columbia University Medical Center will be screened and subjects will be asked to participate if the following criteria are met: Older than 18 years. Symptomatic heart failure (New York Heart Association functional class II-III). Ischemic or non-ischemic cardiomyopathy. Left ventricular ejection fraction (EF) 40% or lower. Peak oxygen uptake (VO2, peak) between 10 and 17 mL O2/min/kg. Be on appropriate, stable medical treatments for heart failure, including (unless shown to be intolerant) a diuretic, an angiotensin-converting enzyme inhibitor and/or angiotensin-receptor blocker and a beta-blocker, pacemaker or ICD or CRT. Exclusion Criteria: Unable to perform treadmill exercise Pregnancy Recent myocardial infarction (within 3 months). Clinically significant angina. Hospitalization for heart failure requiring intravenous treatments within 30 days. Allergy to fish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Jorde, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure

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