- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Kontakter och platser
Studieorter
-
-
Florida
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Gainesville, Florida, Förenta staterna, 32610
- University of Florida
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Undergoing cardiac resynchronization therapy
- Undergoing sinus cannulation
Exclusion Criteria:
- NYHA class II-IV heart failure
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
|
Both groups will have 1 teaspoon of blood drawn for analysis.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Increased extraction of blood-borne ketone bodies
Tidsram: 1 day
|
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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Eileen Handberg, PhD, University of Florida
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201401007
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