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Clinical Trials/NCT02369913
NCT02369913WithdrawnNot Applicable

A Metabolomic Approach to Probing Myocardial Fuel Shifts in Human Heart Failure

University of Florida1 site in 1 countryStarted: March 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Increased extraction of blood-borne ketone bodies

Study Overview

Brief Summary

This proposal is designed to test the hypothesis that humans shift to reliance on ketone bodies as a cardiac fuel source during the development of HF. The investigator also propose that this shift to ketone utilization can be detected by metabolomic profiling of blood.

Specific Aim 1: To determine if the failing human heart exhibits increased extraction of blood-borne ketone bodies. Ketone bodies will be measured in coronary sinus, arterial, and central venous blood samples to determine AV differences. The HF group will be comprised of patients undergoing cardiac resynchronization therapy with an implantable cardioverter-defibrillator. The Control group will be compromised of patients without evidence of structural heart disease who are undergoing catheter ablation for supraventricular tachycardia.

Specific Aim 2: To determine whether blood samples from humans with HF display metabolomic signatures indicative of increased myocardial ketone body utilization. Quantitative targeted metabolomics will be performed on the samples described in Aim 1 to determine if metabolite markers (e.g. C4-OH acylcarnitine, acetylcarnitine, succinate) found to be associated with increased myocardial ketone body oxidation in animal models are increased in the human HF group compared to the controls.

Detailed Description

After subjects agree to participate in this study and are scheduled to have cardiac resynchronization therapy, the research personnel will take 1 teaspoon of blood before and after the scheduled cardiac procedure for comparison.

Once subjects agree to participate in this study and are scheduled to have a catheter ablation procedure, research personnel will take 1 teaspoon of blood during the scheduled cardiac procedure.

These samples will be taken from catheters already placed during the scheduled cardiac procedure.

Blood will be sent to a lab at the Sanford-Burnham Metabolomics Core Facility in Orlando, Florida for analysis.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Undergoing cardiac resynchronization therapy
  • Undergoing sinus cannulation

Exclusion Criteria

  • NYHA class II-IV heart failure

Outcomes

Primary Outcomes

Increased extraction of blood-borne ketone bodies

Time Frame: 1 day

Ketone bodies will be measured in coronary sinus, arterial, and central venous blood samples to determine AV differences

Determine whether heart failure blood samples display metabolomic signatures

Time Frame: 1 day

Quantitative targeted metabolomics will be performed on the samples described in Outcome 1 to determine if metabolite markers (e.g. C4-OH acylcarnitine, acetylcarnitine, succinate) found to be associated with increased myocardial ketone body oxidation in animal models are increased in the human HF group compared to the controls.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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