Myocardial Tissue in Heart Transplantation Clinical Trial
Official title:
Fish Oil Effect on Heart Muscle Cells in Heart Transplant Patients (FOHMC)
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).
50 adult heart transplant recipients (18-75 years of age) entered the maintenance phase (>6
months after heart transplantation), remaining clinically quiescent (See Inclusion criteria)
and undergoing regularly scheduled myocardial biopsies (as part of standard clinical care)
for allograft rejection will be recruited.
Half of the subject will be receive DHA and half DHA+EPA administered orally which will be
administered in two capsules in the morning and two in the evening. Each patient will serve
as their own control, and comparisons will be made between pre and post treatments within
each patient.
Prior to assignment to treatment, a septal biopsy (10 to 20 mg) will be obtained during a
routine biopsy procedure and immediately frozen in liquid nitrogen and stored at -80 until
analysis. Therapy will continue for at least 6 months and until completion of the primary
end point of paired cardiac biopsy acquisition. Cardiac biopsies obtained during regularly
scheduled myocardial biopsies for clinical evaluation for allograft rejection will also be
analyzed for phospholipid fatty acid composition.
The study completion date listed in this record was obtained from the "Completed Date"
entered in the Query View Report System (QVR).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment