Clinical trial NCT03032627: Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
Official title: Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
Collaborators: name: Florida Hospital Cardiovascular Institute
name: Sanford-Burnham Medical Research Institute
First posted: 2017-01-26
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Analyses of collected tissues
timeFrame: Restricted to the time around surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
affiliation: Translational Research Institute for Metabolism and Diabetes
name: Richard E Pratley, MD
role: PRINCIPAL_INVESTIGATOR
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