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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: 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010768
Enrollment
60
Registered
2013-05-29
Start date
2013-05-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

-Olmesartan 40mg -Once daily -Treatment period: 8 months -Olmesartan 20mg and Eplerenone 50mg -Once daily -Treatment period: 8 months

Sponsors

Showa University Northern Yokohama Hospital.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.)

Design outcomes

Primary

MeasureTime frame
-Central blood pressure -Left ventricular mass index (LVMI) -Plasma aldosterone concentration (PAC)

Secondary

MeasureTime frame
-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

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026