Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

NCT03032627 | Active Not Recruiting DMC

• 1 other identifier: TRIMDFH 936207
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Analyses of collected tissues

  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

Study Arms (1)

Cardiac surgery

OTHER

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

Interventions

Collection of discarded heart tissue PROCEDURE

Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.

Cardiac surgery

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are capable of giving informed consent.
• Age 19-89
• Diagnosis of chronic heart failure
• Any patients scheduled for at least one of the following procedures:
• LVAD implantation or as recipient for cardiac transplantation.
• LVAD placement both as bridge to transplant and as destination therapy.
• LVAD explantation
• Valve replacement or repair
• Catheterization and myocardial biopsy for idiopathic cardiomyopathy
• Coronary artery bypass graft (CABG)

You may not qualify if:

• Life expectancy less than 2 weeks
• 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).
• 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.
• Normal cardiac function from medical records
• Pathological remodeling and extensive infarction with limited non-pathological regions of myocardium.
• Abnormal or impaired cardiac function from medical records, which are self determinants for rejection as a donor organ.

Sponsors & Collaborators

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

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (12)

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• Ingwall JS, Weiss RG. Is the failing heart energy starved? On using chemical energy to support cardiac function. Circ Res. 2004 Jul 23;95(2):135-45. doi: 10.1161/01.RES.0000137170.41939.d9.

  PMID: 15271865 BACKGROUND

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• Polak J, Kotrc M, Wedellova Z, Jabor A, Malek I, Kautzner J, Kazdova L, Melenovsky V. Lipolytic effects of B-type natriuretic peptide 1-32 in adipose tissue of heart failure patients compared with healthy controls. J Am Coll Cardiol. 2011 Sep 6;58(11):1119-25. doi: 10.1016/j.jacc.2011.05.042.

  PMID: 21884948 BACKGROUND

• Collins S. A heart-adipose tissue connection in the regulation of energy metabolism. Nat Rev Endocrinol. 2014 Mar;10(3):157-63. doi: 10.1038/nrendo.2013.234. Epub 2013 Dec 3.

  PMID: 24296515 BACKGROUND

• Kovacova Z, Tharp WG, Liu D, Wei W, Xie H, Collins S, Pratley RE. Adipose tissue natriuretic peptide receptor expression is related to insulin sensitivity in obesity and diabetes. Obesity (Silver Spring). 2016 Apr;24(4):820-8. doi: 10.1002/oby.21418. Epub 2016 Feb 17.

  PMID: 26887289 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Richard E Pratley, MD

  Translational Research Institute for Metabolism and Diabetes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 26, 2017
• Study Start: March 20, 2017
• Primary Completion: June 28, 2019
• Study Completion: December 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)