Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients

Jichi Medical University23 enrolled

Overview

The purpose of this study is to determine whether aliskiren is effective in the treatment of blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease (CKD) patients.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Chronic Kidney Disease

Interventions

AliskirenDRUG

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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)

Locations (4)

Niimi city Yukawa National health insurance clinic

Niimi, Okayama-ken, Japan

Konan Hospital

Oyama, Tochigi, Japan

Kurosu Hospital

Sakura, Tochigi, Japan

Jichi Medical University

Shimotsuke, Tochigi, Japan

Outcomes

Primary Outcomes

The Change of Blood Pressure

The change of systolic blood pressure and diastolic blood pressure

Time frame: baseline and 6 month

The Change of Heart Function Confirmed by Echocardiograph

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.

Time frame: baseline and 6 month

The Change of BNP

Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.

Time frame: baseline and 6month

The Change of eGFR

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).

Time frame: baseline and 6 month

The Change of Urine Albumin/ Creatinine Ratio (UACR).

The UACR was measured at baseline, Week12 and Week24

Time frame: baseline and 6 months

Secondary Outcomes

The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM

Time frame: 6 months

Data from ClinicalTrials.gov

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