- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Undergoing cardiac resynchronization therapy
- Undergoing sinus cannulation
Exclusion Criteria:
- NYHA class II-IV heart failure
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Heart failure subjects
Heart failure subjects undergoing cardiac resynchronization will have a blood drawn for this study.
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Both groups will have 1 teaspoon of blood drawn for analysis.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Increased extraction of blood-borne ketone bodies
Periodo de tiempo: 1 day
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Ketone bodies will be measured in coronary sinus, arterial, and central venous blood samples to determine AV differences
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1 day
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Determine whether heart failure blood samples display metabolomic signatures
Periodo de tiempo: 1 day
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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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eileen Handberg, PhD, University of Florida
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201401007
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .