Fish Oil In Heart Transplantation

NCT01072994 | Unknown DMC

• 2 other identifiers: 691P20HL101434
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Myocardial Tissue in Heart Transplantation

Keywords

Myocardium; Phospholipid; Fish oil; Cardiolipin; Transplantation

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Fish Oil DIETARY_SUPPLEMENT

Differential proportional doses of DHA versus DHA and EPA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Central Study Contacts

Mandeep R. Mehra, MBBS, FACC

CONTACT

410-706-8246; mmehra@medicine.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 29, 2016

Record last verified: 2010-02