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

Withdrawn

• Conditions: Heart Failure
• Interventions: Other: Blood Drawn

• Registration Number: NCT02369913
• Lead Sponsor: University of Florida

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 Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-24
• Study Start: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Undergoing cardiac resynchronization therapy
• Undergoing sinus cannulation

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Exclusion Criteria

• NYHA class II-IV heart failure

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure subjects	Blood Drawn	Heart failure subjects undergoing cardiac resynchronization will have a blood drawn for this study.
Heart arrhythmia patients	Blood Drawn	Heart arrhythmia patients undergoing ablation will have a blood drawn for this study.

Primary Outcome Measures

Name	Time	Method
Increased extraction of blood-borne ketone bodies	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	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.

Trial Locations

Locations (1)

University of florida; 🇺🇸 Gainesville, Florida, United States