Myocardial Tissue in Heart Transplantation Clinical Trial
— FOHMCOfficial 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).
| Status | Not yet recruiting |
| Enrollment | 50 |
| Est. completion date | March 2012 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. Age 18-75 years of age at time of cardiac transplantation; 2. Absence of cardiac allograft rejection on the index cardiac biopsy 3. No treatment for cardiac allograft rejection within 30 days of enrollment 4. Absence of restrictive physiology or cardiac allograft dysfunction on hemodynamic assessment 5. Stable immunosuppression and other background medications for past 30 days with no planned modulation in therapy for 6 months 6. All women of childbearing potential must have a negative urine pregnancy test prior to treatment and agree to use adequate contraception (defined as oral or injectable contraceptives, intrauterine devices, surgical sterilization or a combination of a condom and spermicide) or limit sexual activity to vasectomized partner for 3 months after administration of therapy; 7. Ability to sign Informed Consent Form and Release of Medical Information Form Exclusion Criteria: 1. Regular use of u)-3 PUFA supplements (fish oil or flax seed oil). 2. Alcoholism or drug abuse; 3. Poorly controlled diabetes (defined as a Hb A1C >8); 4. Fasting triglycerides >250 mg/dl. 5. Pregnancy and Lactation 6. Persons with known sensitivity or allergy to fish; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cardiac phospholipid fatty acid composition and cardiolipin (CL) content in myocardium | 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). | 6 months | No |