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

NCT00944229 | Terminated Phase 3 Results

• 2 other identifiers: AAAD7501LVZ112854
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; omega 3; lovaza; VO2 max

Outcome Measures

Primary Outcomes (3)

• Change in Peak VO2

  0, 1 and 8 weeks of Omega 3 supplementation.

• Change in Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) After 8 Weeks of Omega 3 Supplementation.

  0 and after 8 weeks of Omega 3 supplementation.

• Change in Base Line Oxidized Low Density Lipoprotein (LDL) Level and in Response to Exercise

  0, 1 and 8 weeks of Omega 3 supplementation.

Study Arms (2)

1 Drug Treatment - LOVAZA

ACTIVE COMPARATOR

Drug Treatment - LOVAZA 4 gm q24 for 8 weeks

Drug: LOVAZA (Omega-3)

2 placebo

PLACEBO COMPARATOR

Placebo 4 capsules q24 for 8 weeks

Drug: Placebo

Interventions

LOVAZA (Omega-3) DRUG

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).

1 Drug Treatment - LOVAZA

Placebo DRUG

4 capsules of placebo every 24 hours

2 placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Omacor; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: CU PRS Administrator
• Organization: Columbia University

crchelp@columbia.edu

212-342-1643

Study Officials

• Ulrich Jorde, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: July 23, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 25, 2016
• Results First Posted: April 22, 2016

Record last verified: 2016-04

Locations

US (1)