Fish Oil In Heart Transplantation (FOHMC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT01072994
First received: February 19, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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).


Condition Intervention
Myocardial Tissue in Heart Transplantation
Dietary Supplement: Fish Oil

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Fish Oil
    Differential proportional doses of DHA versus DHA and EPA
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072994

Contacts
Contact: Mandeep R. Mehra, MBBS, FACC 410-706-8246 mmehra@medicine.umaryland.edu

Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Mandeep R. Mehra, Professor and Head of Cardiology, University of Maryland School of Medicine
ClinicalTrials.gov Identifier: NCT01072994     History of Changes
Other Study ID Numbers: 691
Study First Received: February 19, 2010
Last Updated: February 19, 2010
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Myocardium
Phospholipid
Fish oil
Cardiolipin
Transplantation

ClinicalTrials.gov processed this record on October 30, 2014