- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07737561
Blood Pressure Response to Exercise and Aortic Stiffness in Patients With Cardiovascular-Kidney-Metabolic Syndrome
The Relationship Between Blood Pressure Response to Exercise Testing and Aortic Stiffness in Patients With Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-Kidney-Metabolic (CKM) syndrome is a recently defined clinical syndrome characterized by the coexistence and interaction of cardiovascular disease, chronic kidney disease, and metabolic disorders, including obesity, dyslipidemia, insulin resistance, and type 2 diabetes mellitus. Individuals with CKM syndrome commonly exhibit vascular dysfunction, endothelial impairment, arterial stiffness, and an increased risk of cardiovascular morbidity and mortality. Although exaggerated blood pressure response during exercise has been recognized as an early marker of future hypertension and adverse cardiovascular outcomes, its relationship with aortic stiffness in patients with CKM syndrome has not been adequately investigated.
The aim of this observational study is to evaluate the association between blood pressure response during a clinically indicated exercise stress test and aortic stiffness in adults with CKM syndrome. Eighty patients with physician-diagnosed CKM syndrome who are referred for routine exercise stress testing in the cardiology outpatient clinic will be enrolled. Blood pressure will be measured immediately before and after the exercise test. Aortic stiffness will be assessed using transthoracic echocardiography by calculating the aortic stiffness index (β-index) from systolic and diastolic aortic diameters and concurrent blood pressure measurements. Demographic characteristics, anthropometric measurements, cardiovascular risk factors, medication use, lifestyle characteristics, and clinical data will also be collected. The findings may clarify whether blood pressure response during routine exercise testing can serve as a simple, non-invasive indicator of increased aortic stiffness and improve cardiovascular risk stratification in individuals with CKM syndrome.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emine Tunç Süygün
- Número de teléfono: +90338 226 21 92
- Correo electrónico: fzteminetunc@gmail.com
Ubicaciones de estudio
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Karaman, Turquía (Türkiye)
- Reclutamiento
- Karaman Training and Research Hospital
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Contacto:
- Karaman Training and Research Hospital
- Número de teléfono: +90338 226 30 00
- Correo electrónico: karaman.eah@saglik.gov.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Willing and able to provide written informed consent.
- Aged 18 years or older.
- Diagnosis of Cardiovascular-Kidney-Metabolic (CKM) syndrome.
- Referred by a cardiologist for a clinically indicated exercise stress test as part of routine clinical care.
- Able to perform an exercise stress test.
Exclusion Criteria:
- Physical disability or any medical condition that precludes performing an exercise stress test.
- Diagnosis of major depressive disorder
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients With Cardiovascular-Kidney-Metabolic Syndrome
Adults diagnosed with Cardiovascular-Kidney-Metabolic (CKM) syndrome who are referred by a cardiologist for a clinically indicated exercise stress test as part of routine care.
Participants undergo routine exercise stress testing and transthoracic echocardiography for assessment of aortic stiffness.
Blood pressure response during exercise and aortic stiffness parameters are evaluated to investigate their association.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Association Between the Pre-to-Post Exercise Change in Blood Pressure and Aortic Stiffness
Periodo de tiempo: During a single study visit: immediately before and immediately after the exercise stress test
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The association between the change in blood pressure from immediately before to immediately after a clinically indicated exercise stress test and the aortic stiffness index (β-index) will be evaluated in adults with Cardiovascular-Kidney-Metabolic syndrome.
Systolic and diastolic blood pressure will be measured immediately before and immediately after the exercise test.
Aortic stiffness will be calculated using systolic and diastolic aortic diameters obtained by transthoracic echocardiography together with concurrent blood pressure measurements.
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During a single study visit: immediately before and immediately after the exercise stress test
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Otros números de identificación del estudio
- KMU-TUNCSUYGUN-004
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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