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Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032627
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
Florida Hospital Cardiovascular Institute
Sanford-Burnham Medical Research Institute
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Brief Summary:
The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Collection of discarded heart tissue Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Cardiac surgery
Subjects will be recruited by a coordinator through electronic medical record (EMR) searches to identify those undergoing left ventricle assist device (LVAD) implantation and explantation, heart transplant, valve replacement or repair, endomyocardial biopsy during catheterization, and arterial bypass surgery. Prior to the procedure, potential subjects will be informed about the clinical study and if interested, they will be consented.
Procedure: Collection of discarded heart tissue
Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.




Primary Outcome Measures :
  1. Analyses of collected tissues [ Time Frame: Restricted to the time around surgical procedure ]
    Tissue samples collected during surgery will be analyzed by way of immunoblot and qrtPCR of mRNA for metabolic enzymes on neutralized acid extracts.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects are capable of giving informed consent.
  2. Age 19-89
  3. Diagnosis of chronic heart failure
  4. Any patients scheduled for at least one of the following procedures:

    1. LVAD implantation or as recipient for cardiac transplantation.
    2. LVAD placement both as bridge to transplant and as destination therapy.
    3. LVAD explantation
    4. Valve replacement or repair
    5. Catheterization and myocardial biopsy for idiopathic cardiomyopathy
    6. Coronary artery bypass graft (CABG)

Exclusion Criteria:

  1. Life expectancy less than 2 weeks
  2. Diagnosed with following co-morbidities: cancer, chronic kidney disease (GFR≤30 or serum creatinine >2.1), active infection or treatment with antibiotics or persistent infectious disease (hepatitis, HIV, etc), cirrhosis, active substance abuse and/or alcohol dependence (≥ 14 alcoholic beverages per week).

Control Myocardial Tissue from Donor Hearts Inclusion Criteria

  1. Samples collected from non-failing hearts deemed unsuitable for transplantation by TransLife because of either acute recipient issues or post-harvest evidence of pathology or positive but benign serology.
  2. Normal cardiac function from medical records

Exclusion Criteria:

  1. Pathological remodeling and extensive infarction with limited non-pathological regions of myocardium.
  2. Abnormal or impaired cardiac function from medical records, which are self determinants for rejection as a donor organ.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032627


Locations
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United States, Florida
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Florida Hospital Cardiovascular Institute
Sanford-Burnham Medical Research Institute
Investigators
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Principal Investigator: Richard E Pratley, MD Translational Research Institute for Metabolism and Diabetes
Publications:

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Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT03032627    
Other Study ID Numbers: TRIMDFH 936207
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases