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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
Okayama
-
Niimi, Okayama, Japan, 719-2643
- Niimi city Yukawa National health insurance clinic
-
-
Tochigi
-
Oyama, Tochigi, Japan, 329-0214
- Konan Hospital
-
Sakura, Tochigi, Japan, 329-1395
- Kurosu Hospital
-
Shimotsuke, Tochigi, Japan, 3290498
- Jichi Medical University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The Change of Blood Pressure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline and 6month
|
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
|
baseline and 6month
|
|
The Change of eGFR
Tijdsspanne: 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).
Tijdsspanne: baseline and 6 months
|
The UACR was measured at baseline, Week12 and Week24
|
baseline and 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
Tijdsspanne: 6 months
|
6 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Yoshiyuki Morishita, MD, PhD, Division of Nephrology, Department of Medicine, Jichi Medical University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- JMU-N1
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .