Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

March 12, 2025 updated by: AdventHealth Translational Research Institute
The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Restricted to the time around surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Collaborators

Sanford-Burnham Medical Research Institute
Florida Hospital Cardiovascular Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

June 28, 2019

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimated)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 936207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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