Myocardial Tissue in Heart TransplantationFOHMCNCT01072994
Fish Oil In Heart Transplantation
A study testing Fish Oil in people with Myocardial Tissue in Heart Transplantation, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Tissue in Heart Transplantation
- What is being tested?
- Fish Oil
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official 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.
Read more
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).
Read the 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).
- Being tested
- Fish Oil
- Keywords
- Myocardium, Phospholipid, Fish oil, Cardiolipin, Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Differential proportional doses of DHA versus DHA and EPA
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011 (estimated)
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Tissue in Heart TransplantationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072994
- Sponsor's protocol ID
- 691
- Other IDs
- P20HL101434
- Acronym
- FOHMC
- Status last verified
- Feb 2010
- First submitted
- 19 Feb 2010
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil Effect on Heart Muscle Cells in Heart Transplant Patients (FOHMC)
- ClinicalTrials.gov ID
- NCT01072994
- Acronym / sponsor ID
- FOHMC / 691
- Keywords
- Myocardium, Phospholipid, Fish oil, Cardiolipin, Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilDifferential proportional doses of DHA versus DHA and EPA | Dietary supplement | – |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
Related trials for Myocardial Tissue in Heart Transplantation
RecruitingObservational study
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Congestive Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil in people with Myocardial Tissue in Heart Transplantation, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mandeep R. Mehra, MBBS, FACC (410-706-8246, mmehra@medicine.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac phospholipid fatty acid composition and cardiolipin (CL) content in myocardium (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.