- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072994
Fish Oil In Heart Transplantation (FOHMC)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mandeep R. Mehra, MBBS, FACC
- Phone Number: 410-706-8246
- Email: mmehra@medicine.umaryland.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-75 years of age at time of cardiac transplantation;
- Absence of cardiac allograft rejection on the index cardiac biopsy
- No treatment for cardiac allograft rejection within 30 days of enrollment
- Absence of restrictive physiology or cardiac allograft dysfunction on hemodynamic assessment
- Stable immunosuppression and other background medications for past 30 days with no planned modulation in therapy for 6 months
- 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;
- Ability to sign Informed Consent Form and Release of Medical Information Form
Exclusion Criteria:
- Regular use of u)-3 PUFA supplements (fish oil or flax seed oil).
- Alcoholism or drug abuse;
- Poorly controlled diabetes (defined as a Hb A1C >8);
- Fasting triglycerides >250 mg/dl.
- Pregnancy and Lactation
- Persons with known sensitivity or allergy to fish;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac phospholipid fatty acid composition and cardiolipin (CL) content in myocardium
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 691
- P20HL101434 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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