- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04522765
Patrones diurnos de PA en personas con mayor riesgo de ECV
Tensión arterial diurna y patrones de rigidez arterial en personas con mayor riesgo de enfermedad cardiovascular
In health, blood pressure (BP) falls at night by >10% compared with day-time values. This natural dipping pattern is important as without it there is an increased risk of cardiovascular disease (CVD). Recent evidence suggests that chronotherapy (taking anti-hypertensive medication at bedtime instead of in the morning) may enhance nocturnal BP dipping and reduce the risk of CVD events. There is therefore an urgent need to characterise diurnal BP patterns in patients who may be at risk of reduced nocturnal dipping in order to maximise protective therapy in all those who would benefit. Similarly, it has previously been demonstrated that increased arterial stiffness is associated with increased CVD risk, however little is known about whether loss of diurnal variations in arterial stiffness confer addition risk. Kidney disease is independently associated with increased CVD events, but the exact makeup of this risk is not clear. Within this heterogenous cohort several very distinct groups exist including those with acute kidney injury (AKI), chronic kidney disease (CKD), inflammatory conditions like small vessel vasculitis (SVV), and those who have either donated or received a kidney transplant. Diurnal BP and arterial stiffness patterns within these patient groups are not well characterised. The investigators will recruit patients at increased risk of CVD from the Royal Infirmary of Edinburgh Renal and Vasculitis Clinics. Participants will undergo 24-hour ambulatory BP and arterial stiffness measurement in conjunction with day- and night-time blood and urine sampling on two separate occasions. This study aims to characterise diurnal patterns of BP and arterial stiffness in patients at increased risk of CVD and compare findings with healthy controls. In doing so, the investigators aim to allow more targeted CVD risk reduction strategies and improve long-term patient outcomes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Neeraj Dhaun, MBChB PhD
- Número de teléfono: 07968810899
- Correo electrónico: bean.dhaun@ed.ac.uk
Ubicaciones de estudio
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Edinburgh, Reino Unido, EH164SA
- Reclutamiento
- Royal Infirmary of Edinburgh
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Contacto:
- Neeraj Dhaun, MBChB PhD
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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
As above
Descripción
Inclusion Criteria:
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Patients will be eligible to take part in the study if they attend NHS Lothian inpatient or outpatient services and can be classified as being at increased risk of CVD. This will include, but is not limited to, the following subgroups:
- CKD as defined by the Kidney Disease Outcome Quality Initiative (K/DOQI) classification
- AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification
- Small vessel vasculitis
- Kidney transplant recipient
- Kidney donor We will also recruit a healthy control group from the community.
Exclusion Criteria:
- Age <18 years and >90 years
- Lack of ability to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Health
Healthy individuals with no known medical condition and taking no regular medication |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Acute kidney injury
Individuals with acute kidney injury as defined by KDIGO criteria |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Chronic kidney disease
Individuals with chronic kidney disease as defined by KDIGO criteria |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Small vessel vasculitis
Individuals with active small vessel vasculitis an diagnosed by a specialist physician |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Kidney transplant recipient
Individuals who have received a kidney transplant |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Kidney donor
Individuals who have donated a kidney for transplantation |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Nocturnal BP dip
Periodo de tiempo: 24 hours
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Percentage change between mean day-time and mean night-time blood pressure |
24 hours
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|
Nocturnal arterial stiffness dip
Periodo de tiempo: 24 hours
|
Percentage change between mean day-time and mean night-time arterial stiffness |
24 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in urine ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)
Periodo de tiempo: Morning (06:00-12:00) and evening (18:00-00:00)
|
Measurement of urine ET-1 concentration in the morning (06:00 - 12:00) and in the evening (18:00-00:00) |
Morning (06:00-12:00) and evening (18:00-00:00)
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|
Change in plasma ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)
Periodo de tiempo: Morning (06:00-12:00) and evening (18:00-00:00)
|
Measurement of plasma ET-1 concentration in the morning (06:00 - 12:00) and in the evening (18:00-00:00) |
Morning (06:00-12:00) and evening (18:00-00:00)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Neeraj Dhaun, MBChB PhD, University of Edinburgh
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
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Fenómenos fisiológicos circulatorios y respiratorios
- Examen físico
- Signos vitales
- Hemodinámica
- Fenómenos fisiológicos cardiovasculares
- Presión arterial
- Rigidez vascular
Otros números de identificación del estudio
- AC19178
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
There is no plan to share 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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