Unique ID issued by UMIN | UMIN000010768 |
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Receipt number | R000012590 |
Scientific Title | High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease: a single-center, prospective, randomized, open-labes study |
Date of disclosure of the study information | 2013/05/29 |
Last modified on | 2015/12/25 22:51:01 |
High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease: a single-center, prospective, randomized, open-labes study
High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease
High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease: a single-center, prospective, randomized, open-labes study
High-dose angiotensin II receptor blocker (ARB), olmesartan, monotherapy versus combination therapy of normal-dose olmesartan with selective aldosterone antagonist, selara, treatment on central blood pressure in patients with ischemic heart disease
Japan |
Hypertension
Cardiology |
Others
NO
Hypertension is an important risk factor for cardiovascular disease.
Our purpose is to compare the effect of High-dose angiotensin II receptor blocker (ARB) monotherapy versus combination therapy of normal-dose ARB with selective aldosterone antagonist treatment on central blodd pressure, left ventricular mass index (LVMI), and plasma aldosterone concentration (PAC) in hypertensive patients with ischemic heart disease.
Efficacy
-Central blood pressure
-Left ventricular mass index (LVMI)
-Plasma aldosterone concentration (PAC)
-Casual blood pressure (SBP and DBP)
-Plasma renin activity
-LVEDP
-Left atrial dimension, E/A, and E/E' ration seen by echo-cardiographic measurement
-Urine albumin
-Pulse Wave Velocity
-ECG
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
Central registration
2
Treatment
Medicine |
-Olmesartan 40mg
-Once daily
-Treatment period: 8 months
-Olmesartan 20mg and Eplerenone 50mg
-Once daily
-Treatment period: 8 months
20 | years-old | <= |
85 | years-old | > |
Male and Female
1) ischemic heart disease patients
2) clinic SBP >=130 mmHg and/or DBP >=80 mmHg
3) ability of oral administration
4) male or female subjects over 20 years of age and under 85 years of age at the time of informed consent
5) eGFR >= 50 ml/min/1.73m2
6) serum potassium < 5.0 mEq/L
7) ability to provide written informed consent
1) myocardial infarction
2) subjects who already have Olmesartan or Eplerenone at the entry
3) history of allergy against these drugs or similar compounds
4) subjects whose serum potassium level is over 5.0mEq/L
5) Diabetes mellitus patients whose albumin excretion rates > 300mg/24hours
6) subjects with moderate renal dysfunction (eGFR <50 ml/min/1.73m2)
7) hepatic dysfunction (Child-Pugh C)
8) subjects taking potassium supplements, potassium saving diuretics, or strong CYP3A4-inhibitors (Itraconazol, Ritonavir, and Nelfinavir)
9) Pregnancy
10) Additionally, patient who judged that doctor in charge is improper (For example, FH or secondary hyperlipidemia, tumor, administering cyclosporine, drug abuse or alcoholism, hypothyroidism and inherited stripe disease or the family medical histories, previous history of medicinal muscle disorder.)
60
1st name | |
Middle name | |
Last name | Myong Hwa Yamamoto |
Showa University Northern Yokohama Hospital.
Division of cardiology and cardiac catheterization laboratory
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa
1st name | |
Middle name | |
Last name |
Showa University Northern Yokohama Hospital
Division of cardiology and cardiac catheterization laboratory
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa
Showa University Northern Yokohama Hospital.
None
Self funding
NO
2013 | Year | 05 | Month | 29 | Day |
Unpublished
Terminated
2013 | Year | 05 | Month | 29 | Day |
2013 | Year | 05 | Month | 29 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2013 | Year | 05 | Month | 20 | Day |
2015 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012590
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