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OpenTrials
Active, Not Recruiting

NCT Number: NCT03032627

Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

19 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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.

Treatment and study plan

Collection of discarded heart tissue

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Collaborators

  • Florida Hospital Cardiovascular Institute
  • Sanford-Burnham Medical Research Institute

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2025
First posted
Jan 26, 2017
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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