Hypertensive patients Hypertension
Conditions
Interventions
Esaxerenone is given orally once daily for 12 weeks. The typical initial dose will be started at 2.5 mg and titrated to 5 mg.
Sponsors
Katsuya Tomohiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be included if they meet all of the following inclusion criteria: 1) Patients aged 20 years or older at informed consent 2) Hypertensive patients treated with an antihypertensive drug (ARB or CCB) at regular dose for at least 4 weeks prior to the first day of Esaxerenone treatment 3) Patients with a mean systolic blood pressure =>125 mmHg and/or diastolic blood pressure =>75 mmHg in the last 5 days of early morning home blood pressure measured by a brachial sphygmomanometer
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded. 1) Patients diagnosed with secondary hypertension (endocrine hypertension, hypertension due to single kidney, etc.) 2) Hyperkalemia patients or patients whose serum potassium level exceeds 5.0 mEq/L 3) Patients with severe renal impairment (eGFR< 30 mL/min/1.73m2). 4) Patients with severe liver dysfunction (liver failure, cirrhosis, etc.) 5) Patients hospitalized for myocardial infarction/heart failure, underwent percutaneous coronary angioplasty/coronary artery bypass surgery, and developed cerebral infarction/cerebral hemorrhage/subarachnoid hemorrhage/transient ischemic attack within 12 weeks before obtaining informed consent. 6) Patients diagnosed with life expectancy within one year due to some diseases 7) Patients diagnosed with dementia 8) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant 9) Patients who are inappropriate for this study judged by their primary physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in early morning home blood pressure (systolic and diastolic blood pressure) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy 1) Change from baseline in office blood pressure and bedtime home blood pressure (systolic and diastolic blood pressure) 2) Change in each blood pressure (office, early morning and bedtime (systolic and diastolic blood pressure)) 3) Achieving rate of each target blood pressure (office, early morning and bedtime (systolic and diastolic blood pressure)) 4) Change in PAC, PRA, and ARR 5) Change and %change from baseline in serum NT-proBNP 6) Threshold achieving rate for heart failure diagnosis of serum NT-proBNP values(<55 pg/mL, <125 pg/mL) 7) Change and %change from baseline in UACR 8) Change from baseline in urinary biomarkers (Na, K, Na/K, and Cr) 9) Correlations between change in each blood pressure from baseline and urinary Na/K ratio or estimated daily salt intake and salt check sheet 10) Correlation between urinary Na/K ratio and estimated daily salt intake 11) Stratified analysis across the tertiles of urinary Na/K ratio, and estimated daily salt intake and salt check sheet (change from baseline in office, early morning and bedtime blood pressure, and %change from baseline in NT-proBNP and UACR) 2. Exploratory evaluation 1) Evaluate the change of behavior index w/wo use of mobile application [behavior index] [changes in office blood pressure, early morning and bedtime home blood pressure (systolic and diastolic blood pressure), and estimated daily salt intake] 2) Correlations between dietary Na intake estimated from the mobile application and estimated 24-h urinary Na excretion 3) Correlations between dietary K intake estimated from the mobile application and estimated 24-h urinary K excretion 4) Correlations between dietary Na/K ratio estimated from mobile application and urinary Na/K ratio 3. Safety 1) Incidence of adverse events 2) Time course in eGFR and change from baseline in eGFR calculated from serum creatinine 3) Percentage of study subjects with serum potassium levels:5.5 mEq/L or more, 6.0 mEq/L or more 4) Time course of serum po | — |
Contacts
Public ContactTomohiro Katsuya
Katsuya Clinic
Outcome results
None listed