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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
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Okayama
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Niimi, Okayama, Japon, 719-2643
- Niimi city Yukawa National health insurance clinic
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Tochigi
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Oyama, Tochigi, Japon, 329-0214
- Konan Hospital
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Sakura, Tochigi, Japon, 329-1395
- Kurosu Hospital
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Shimotsuke, Tochigi, Japon, 3290498
- Jichi Medical University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Aliskiren
|
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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The Change of Blood Pressure
Délai: baseline and 6 month
|
The change of systolic blood pressure and diastolic blood pressure
|
baseline and 6 month
|
|
The Change of Heart Function Confirmed by Echocardiograph
Délai: 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
Délai: baseline and 6month
|
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
|
baseline and 6month
|
|
The Change of eGFR
Délai: 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
|
|
The Change of Urine Albumin/ Creatinine Ratio (UACR).
Délai: baseline and 6 months
|
The UACR was measured at baseline, Week12 and Week24
|
baseline and 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
Délai: 6 months
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yoshiyuki Morishita, MD, PhD, Division of Nephrology, Department of Medicine, Jichi Medical University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JMU-N1
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