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Fish Oil In Heart Transplantation

NCT01072994 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-07-29

No results posted yet for this study

Summary

Despite aggressive treatment, patients with heart failure have a poor prognosis. Docosahexaenoic acid (DHA), an omega-3 polyunsaturated fatty acids found in fish oils, may prevent the progressions of heart failure through mechanisms that are not addressed with current drugs.

The omega-3 polyunsaturated fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic acid (EPA) favorably impact mitochondrial dysfunction and chronic inflammation in heart failure (HF). Treatment with DHA-t-EPA alters cardiac phospholipid composition by decreasing arachidonic acid (a pro-inflammatory fatty acid) and increasing DHA and the mitochondrial phospholipid cardiolipin, with is associated with improved Left Ventricular (LV) function.

Fish oil supplements contain a mix of DHA and EPA, however we postulate that DHA is superior to EPA in improving mitochondrial function and suppressing inflammation, and thus DHA should be used to treat HF.

Cardiac phospholipid fatty acid composition (i.e. DHA, EPA, and arachidonic acid) and cardiolipin (CL) content will be measured in biopsies from stable heart transplantation patients that are obtained as part of standard clinical care in heart transplant patients before and after treatment with DHA alone or DHA+EPA. We will compare cardiac phospholipid composition from biopsies obtained at study entry and at 6 months follow-up (allowable range +/- two months, depending on patients' clinical conditions).

Conditions

  • Myocardial Tissue in Heart Transplantation

Interventions

DIETARY_SUPPLEMENT

Fish Oil

Differential proportional doses of DHA versus DHA and EPA

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-04-30
Completion
2012-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01072994 on ClinicalTrials.gov