- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01442883
Renal Nerve Ablation in Chronic Kidney Disease Patients
Understanding the Mechanisms of Progressive Decrease in Blood Pressure After Renal Nerve Ablation
In patients with treatment resistent hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labelling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:
Short term effects:
A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation
Long term effects:
D)Decrease of total sodium content after 6 and 12 months. E)Improvement of vascular wall properties after 6 and 12 months
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Erlangen, Alemania, 91054
- Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
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Lübeck, Alemania
- Joachim Weil
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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:
- treatment resistant hypertension
- chronic kidney disease 3 - 5
- male of female aged over 18 years
- written informed consent
- agreement to attend all study visits as planned in the protocol
Exclusion Criteria:
- any contraindications for MRI
- claustrophobia
- strabismus
- severe ocular diseases
- history of epilepsia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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treatment resistant hypertensives with CKD 3-5
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percutaneous selective renal sympathetic nerve ablation with the use of the Simplicity Catheter system
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
office BP
Periodo de tiempo: baseline, 6 months
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Change in office blood pressure from baseline to 6 months post-renal nerve ablation
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baseline, 6 months
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24-h ABPM
Periodo de tiempo: baseline, 6 months
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Change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal nerve ablation
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baseline, 6 months
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Magnetic resonance imaging (MRI)
Periodo de tiempo: baseline, 6 months
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baseline, 6 months
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Albuminuria
Periodo de tiempo: baseline, 6 months
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Change in urinary albumin/creatinine ratio from baseline to 6 months post renal nerve ablation (spot urine)
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baseline, 6 months
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local RAS activity
Periodo de tiempo: baseline, 6 months
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Change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal nerve ablation
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baseline, 6 months
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systemic RAS activity
Periodo de tiempo: baseline, 6 months
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baseline, 6 months
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vascular structure and function of large and small arteries
Periodo de tiempo: baseline, 6 months
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baseline, 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
BP
Periodo de tiempo: 1 and 12 months
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1 and 12 months
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local RAS activity
Periodo de tiempo: 1 day and 1 months
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Change in urinary angiotensinogen concentration from the morning spot urine from baseline to 1 day and 1 months post-renal nerve ablation
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1 day and 1 months
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systemic RAS activity
Periodo de tiempo: 1 day and 1 months
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1 day and 1 months
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vascular structure and function of large and small arteries
Periodo de tiempo: 12 months
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12 months
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MRI
Periodo de tiempo: 1 day, 1 and 12 months
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1 day, 1 and 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Roland E Schmieder, MD, University of Erlangen-Nürnberg, Germany
Publicaciones y enlaces útiles
Publicaciones Generales
- Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.
- Schmid A, Schmieder R, Lell M, Janka R, Veelken R, Schmieder RE, Uder M, Ott C. Mid-Term Vascular Safety of Renal Denervation Assessed by Follow-up MR Imaging. Cardiovasc Intervent Radiol. 2016 Mar;39(3):426-32. doi: 10.1007/s00270-015-1192-2. Epub 2015 Aug 8.
- Ott C, Mahfoud F, Schmid A, Toennes SW, Ewen S, Ditting T, Veelken R, Ukena C, Uder M, Bohm M, Schmieder RE. Renal denervation preserves renal function in patients with chronic kidney disease and resistant hypertension. J Hypertens. 2015 Jun;33(6):1261-6. doi: 10.1097/HJH.0000000000000556.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RNA-CKD3-5
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