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Clinical Trials/NCT03032627
NCT03032627
Active, not recruiting
Not Applicable

Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

AdventHealth Translational Research Institute1 site in 1 country55 target enrollmentMarch 20, 2017
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ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
AdventHealth Translational Research Institute
Enrollment
55
Locations
1
Primary Endpoint
Analyses of collected tissues
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 20, 2017
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
AdventHealth Translational Research Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Subjects are capable of giving informed consent.
  • •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)

Exclusion Criteria

  • •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).
  • •Control Myocardial Tissue from Donor Hearts Inclusion Criteria
  • •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
  • •Exclusion Criteria:
  • •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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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