Fish Oil In Heart Transplantation (FOHMC)
Recruitment status was Not yet recruiting
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Fish Oil Effect on Heart Muscle Cells in Heart Transplant Patients (FOHMC)|
- Cardiac phospholipid fatty acid composition and cardiolipin (CL) content in myocardium [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 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 schedule).
|Study Start Date:||April 2010|
|Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Dietary Supplement: Fish Oil
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072994
|Contact: Mandeep R. Mehra, MBBS, FACCemail@example.com|