ENaK study

Not Applicable

• Conditions: Hypertensive patients; Hypertension

• Registration Number: JPRN-jRCTs031210273
• Lead Sponsor: Katsuya Tomohiro

Brief Summary

Esaxerenone significantly reduced morning home BP as well as bedtime home and office BP, and also significantly decreased NT-proBNP and UACR in patients with essential hypertension inadequately controlled with an ARB or a CCB. These effects were consistent regardless of concomitant use of antihypertensive drugs (ARB and CCB) and were achieved without clinically relevant serum potassium elevation or any new safety concerns.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Study Completion: 2022-06-22
• Results First Posted: 2024-01-11
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 126

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified