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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
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Okayama
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Niimi, Okayama, Japan, 719-2643
- Niimi city Yukawa National health insurance clinic
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Tochigi
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Oyama, Tochigi, Japan, 329-0214
- Konan Hospital
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Sakura, Tochigi, Japan, 329-1395
- Kurosu Hospital
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Shimotsuke, Tochigi, Japan, 3290498
- Jichi Medical University
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Aliskiren
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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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Change of Blood Pressure
Tidsramme: baseline and 6 month
|
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
Tidsramme: 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
Tidsramme: baseline and 6month
|
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
|
baseline and 6month
|
|
The Change of eGFR
Tidsramme: 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).
Tidsramme: baseline and 6 months
|
The UACR was measured at baseline, Week12 and Week24
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baseline and 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
Tidsramme: 6 months
|
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Yoshiyuki Morishita, MD, PhD, Division of Nephrology, Department of Medicine, Jichi Medical University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JMU-N1
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