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Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

Sponsor
AdventHealth Translational Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03032627
Collaborator
Florida Hospital Cardiovascular Institute (Other), Sanford-Burnham Medical Research Institute (Other)
55
Enrollment
1
Location
1
Arm
69.4
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Collection of discarded heart tissue
 N/A

Study Design

Study Type:
Interventional
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
Actual Study Start Date :
Mar 20, 2017
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Analyses of collected tissues [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

  5. LVAD implantation or as recipient for cardiac transplantation.

  6. LVAD placement both as bridge to transplant and as destination therapy.

  7. LVAD explantation

  8. Valve replacement or repair

  9. Catheterization and myocardial biopsy for idiopathic cardiomyopathy

  10. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Translational Research Institute for Metabolism and Diabetes Orlando Florida United States 32804

Sponsors and Collaborators

  • AdventHealth Translational Research Institute
  • Florida Hospital Cardiovascular Institute
  • Sanford-Burnham Medical Research Institute

Investigators

  • Principal Investigator: Richard E Pratley, MD, Translational Research Institute for Metabolism and Diabetes

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier:
NCT03032627
Other Study ID Numbers:
  • TRIMDFH 936207
First Posted:
Jan 26, 2017
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Apr 14, 2022