Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients
Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic kidney disease (CKD) was reported to be affecting 11% of the all population. This number is much higher in the elderly population and may be as high as 30%. CKD is an independent risk factor of cardiovascular disease (CVD). This is called "Cardio-renal Continuum". The renin-angiotensin-aldosterone system (RAS) plays pivotal roles in both cardiovascular and renal functions.
The increased oxidative stress by activated RAS on vascular endothelium is one of important factor to development of Cardio-renal Continuum. The blockade of RAS by angiotensin I converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) has been reported to ameliorate the renal disease and CVD; however,they do not completely suppress RAS, leading to a reactive rise in plasma renin activity (PRA). Aliskiren, an oral direct renin inhibitor, is effective against essential hypertension by reducing PRA, resulting in more complete suppression of RAS; however, little is known about the effects of aliskiren on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of aliskiren on heart and kidney functions in elderly hypertensive CKD patients.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Okayama
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Niimi, Okayama, Japón, 719-2643
- Niimi city Yukawa National health insurance clinic
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Tochigi
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Oyama, Tochigi, Japón, 329-0214
- Konan Hospital
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Sakura, Tochigi, Japón, 329-1395
- Kurosu Hospital
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Shimotsuke, Tochigi, Japón, 3290498
- Jichi Medical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical diagnosis of Chronic kidney disease
- Clinical diagnosis of Hypertension (Blood pressure >=140/90mmHg)
- Elderly people(>=65 years old)
Exclusion Criteria:
- The patients who are already taking aliskiren
- The patients who are receiving hemodialysis or peritoneal dialysis
- The patients who are taking cyclosporin
- The patients who have hyperkalemia(>=5.5mEq/ml)
- Severe heart failure (>=NYHA class III)
- Insulin dependent diabetic mellitus or poor controlled insulin independent diabetic mellitus (>=HbA1c 9.0&)
- Severe liver dysfunction (five folds increased AST or ALT than standard values)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Aliskirén
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150mg/day for all as initial dose, 300mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Change of Blood Pressure
Periodo de tiempo: baseline and 6 month
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The change of systolic blood pressure and diastolic blood pressure
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baseline and 6 month
|
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The Change of Heart Function Confirmed by Echocardiograph
Periodo de tiempo: baseline and 6 month
|
Left ventricular ejection fraction (LVEF)were measured by echocardiogram at baseline and 6 month.
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
|
baseline and 6 month
|
|
The Change of BNP
Periodo de tiempo: baseline and 6month
|
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
|
baseline and 6month
|
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The Change of eGFR
Periodo de tiempo: baseline and 6 month
|
eGFR was calculated at baseline and at 6 month using a modified version of the Modification of Diet in Renal Disease (MDRD) formula of the Japanese Society of Nephrology as follows: eGFR (ml/min/1.73
m2) = 194 × age-0.287
× serum creatinine-1.094
(multiplied by 0.739 for females).
|
baseline and 6 month
|
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The Change of Urine Albumin/ Creatinine Ratio (UACR).
Periodo de tiempo: baseline and 6 months
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The UACR was measured at baseline, Week12 and Week24
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baseline and 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
Periodo de tiempo: 6 months
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6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yoshiyuki Morishita, MD, PhD, Division of Nephrology, Department of Medicine, Jichi Medical University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- JMU-N1
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