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Polyunsaturated Fatty Acid

1 Drug Treatment - LOVAZA for Congestive Heart Failure

Phase 3
Waitlist Available
Led By Ulrich Jorde, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

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.

Eligible Conditions
  • Congestive Heart Failure
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 1 Drug Treatment - LOVAZAActive Control1 Intervention
Drug Treatment - LOVAZA 4 gm q24 for 8 weeks
Group II: 2 placeboPlacebo Group1 Intervention
Placebo 4 capsules q24 for 8 weeks

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,273 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,802 Previous Clinical Trials
8,377,944 Total Patients Enrolled
Ulrich Jorde, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
34 Total Patients Enrolled
~4 spots leftby Nov 2025
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