ESES-LVH study
- Conditions
- Hypertensive Patients with Left Ventricular Hypertrophy
- Registration Number
- JPRN-jRCTs071190043
- Lead Sponsor
- Tsujita Kenichi
- Brief Summary
Esaxerenone showed stable antihypertensive effect and regression effect on left ventricular hypertrophy (reduction of LVMI) regardless of the kind of basal antihypertensive agent (RA inhibitor or CCB). No new unpredictable AEs or ADRs were observed, and safety of esaxerenone have been confirmed. It is suggested that esaxerenone can be clinically useful option as the second-line treatment for hypertensive patients with cardiac hypertrophy who had uncontrolled BP under treatment with RA inhibitor or CCB.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
1)Patients with hypertension (early morning home blood pressure [BP]: =>135 mmHg and <=159 mmHg of systolic blood pressure and/or =>85 mmHg and <=99 mmHg of diastolic blood pressure)
2)Patients with left ventricular hypertrophy.
3)Patients treated with renin-angiotensin inhibitor or Ca-antagonist.
4)Patients aged 20 years or older.
1)Patients with a diagnosis of secondary hypertension or malignant hypertension.
2)Patients with orthostatic hypotension or a history of orthostatic hypotension.
3)Patients with any of the cerebro-cardiovascular diseases.
4)Patients with type 1 diabetes.
5)Hyperkalemia patients, patients whose serum potassium level exceeds 5.0 mEq/L, etc.
6)Patients who the investigator judges to be unsuitable for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Change in sitting BP (early morning home BP) between baseline values and values at the end of administration of Esaxerenone.<br>2)Amount and rate of change in left ventricular mass index (LVMI) between baseline values and values at the end of administration of Esaxerenone.
- Secondary Outcome Measures
Name Time Method