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Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

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ClinicalTrials.gov Identifier: NCT03032627
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : March 19, 2021
Sponsor:
Collaborators:
Florida Hospital Cardiovascular Institute
Sanford-Burnham Medical Research Institute
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date March 19, 2021
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
Official Title  ICMJE Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
Brief Summary The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Heart Failure
Intervention  ICMJE Procedure: Collection of discarded heart tissue
Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.
Study Arms  ICMJE 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.
Intervention: Procedure: Collection of discarded heart tissue
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 9, 2020)
55
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
165
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032627
Other Study ID Numbers  ICMJE TRIMDFH 936207
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Translational Research Institute for Metabolism and Diabetes, Florida
Study Sponsor  ICMJE Translational Research Institute for Metabolism and Diabetes, Florida
Collaborators  ICMJE
  • Florida Hospital Cardiovascular Institute
  • Sanford-Burnham Medical Research Institute
Investigators  ICMJE
Principal Investigator: Richard E Pratley, MD Translational Research Institute for Metabolism and Diabetes
PRS Account Translational Research Institute for Metabolism and Diabetes, Florida
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP