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

NCT02369913 | Withdrawn

• 1 other identifier: 201401007
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

  1 day

• Determine whether heart failure blood samples display metabolomic signatures

  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.

  1 day

Study Arms (2)

Heart failure subjects

Heart failure subjects undergoing cardiac resynchronization will have a blood drawn for this study.

Other: Blood Drawn

Heart arrhythmia patients

Heart arrhythmia patients undergoing ablation will have a blood drawn for this study.

Other: Blood Drawn

Interventions

Blood Drawn OTHER

Both groups will have 1 teaspoon of blood drawn for analysis.

Heart arrhythmia patients; Heart failure subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing cardiac resynchronization therapy or receiving a catheter ablation procedure.

You may qualify if:

• Undergoing cardiac resynchronization therapy
• Undergoing sinus cannulation

You may not qualify if:

• NYHA class II-IV heart failure

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Eileen Handberg, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 24, 2015
• Study Start: March 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

US (1)