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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Okayama
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Niimi, Okayama, 일본, 719-2643
- Niimi city Yukawa National health insurance clinic
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Tochigi
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Oyama, Tochigi, 일본, 329-0214
- Konan Hospital
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Sakura, Tochigi, 일본, 329-1395
- Kurosu Hospital
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Shimotsuke, Tochigi, 일본, 3290498
- Jichi Medical University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 알리스키렌
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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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Change of Blood Pressure
기간: 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
기간: baseline and 6 month
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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.
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baseline and 6 month
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The Change of BNP
기간: baseline and 6month
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Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
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baseline and 6month
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The Change of eGFR
기간: baseline and 6 month
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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).
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baseline and 6 month
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The Change of Urine Albumin/ Creatinine Ratio (UACR).
기간: 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
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2차 결과 측정
결과 측정 |
기간 |
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The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
기간: 6 months
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yoshiyuki Morishita, MD, PhD, Division of Nephrology, Department of Medicine, Jichi Medical University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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