Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

Not Applicable

Active, not recruiting

• Conditions: Heart Failure
• Interventions: Procedure: Collection of discarded heart tissue

• Registration Number: NCT03032627
• Lead Sponsor: AdventHealth Translational Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Study Start: 2017-03-20
• Primary Completion: 2019-06-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac surgery	Collection of discarded heart tissue	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States