- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02369913
A Metabolomic Approach to Probing Myocardial Fuel Shifts in Human Heart Failure
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Florida
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Gainesville, Florida, Forenede Stater, 32610
- University of Florida
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Undergoing cardiac resynchronization therapy
- Undergoing sinus cannulation
Exclusion Criteria:
- NYHA class II-IV heart failure
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Heart failure subjects
Heart failure subjects undergoing cardiac resynchronization will have a blood drawn for this study.
|
Both groups will have 1 teaspoon of blood drawn for analysis.
|
|
Heart arrhythmia patients
Heart arrhythmia patients undergoing ablation will have a blood drawn for this study.
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Both groups will have 1 teaspoon of blood drawn for analysis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Increased extraction of blood-borne ketone bodies
Tidsramme: 1 day
|
Ketone bodies will be measured in coronary sinus, arterial, and central venous blood samples to determine AV differences
|
1 day
|
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Determine whether heart failure blood samples display metabolomic signatures
Tidsramme: 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.
|
1 day
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Eileen Handberg, PhD, University of Florida
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201401007
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