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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Blood Pressure | The change of systolic blood pressure and diastolic blood pressure | 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. | baseline and 6 month |
| The Change of BNP | Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month. | 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). | baseline and 6 month |
| The Change of Urine Albumin/ Creatinine Ratio (UACR). | The UACR was measured at baseline, Week12 and Week24 | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshiyuki Morishita, MD, PhD | Division of Nephrology, Department of Medicine, Jichi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niimi city Yukawa National health insurance clinic | Niimi | Okayama-ken | 719-2643 | Japan | ||
| Konan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21124333 | Background | Morishita Y, Hanawa S, Chinda J, Iimura O, Tsunematsu S, Kusano E. Effects of aliskiren on blood pressure and the predictive biomarkers for cardiovascular disease in hemodialysis-dependent chronic kidney disease patients with hypertension. Hypertens Res. 2011 Mar;34(3):308-13. doi: 10.1038/hr.2010.238. Epub 2010 Dec 2. |
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4 week observation period to fix any drugs, including existing antihypertensives
Patients were recruited between February 2011 and December 2011 in Tochigi prefecture and Okayama prefecture in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren | Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change of Blood Pressure | The change of systolic blood pressure and diastolic blood pressure | We analyzed all patients who completed study. | Posted | Mean | Standard Deviation | mmHg | baseline and 6 month |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aliskiren |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoshiyuki Morishita | Division of Nephrology, Department of Internal Medicine, Jichi Medical University | 81-285-58-7346 | ymori@jichi.ac.jp |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D000092502 | Renin Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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|
| Oyama |
| Tochigi |
| 329-0214 |
| Japan |
| Kurosu Hospital | Sakura | Tochigi | 329-1395 | Japan |
| Jichi Medical University | Shimotsuke | Tochigi | 3290498 | Japan |
| dizziness |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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. | We analyzed participants who copmleted this study | Posted | Mean | Standard Deviation | % of stroke vulume/enddiastolic volume | baseline and 6 month |
|
|
|
| Primary | The Change of BNP | Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month. | We analyzed all patients who completed study. | Posted | Mean | Standard Deviation | pg/ml | baseline and 6month |
|
|
|
| Secondary | The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM | Not Posted | 6 months |
| Primary | 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). | We analyzed all patients who completed study. | Posted | Mean | Standard Deviation | mL/min/1.73m2 | baseline and 6 month |
|
|
|
| Primary | The Change of Urine Albumin/ Creatinine Ratio (UACR). | The UACR was measured at baseline, Week12 and Week24 | We analyzed all patients who completed this study. | Posted | Mean | Standard Deviation | mg/g | baseline and 6 months |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
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| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |