ESES-LVH study

JRCT ID: jRCTs071190043

Registered date:24/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hypertensive Patients with Left Ventricular Hypertrophy
• Date of first enrollment: 26/06/2020
• Target sample size: 120
• Study type: Interventional
• Intervention(s): The duration of treatment with Esaxelenone is 24 weeks. Esaxelenone is given orally once daily. The initial daily doses will be started at 2.5 mg and titrated (if the effect is insufficient, the dose may be increased up to 5 mg) depending on the patient's condition. Dose reduction criteria patients should be started with 1.25 mg of Esaxelenone.

Outcome(s)

Primary Outcome

1)Change in sitting BP (early morning home BP) between baseline values and values at the end of administration of Esaxerenone.
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

1)Change in sitting BP (early morning home BP) between baseline and 12 weeks after the start of Esaxerenone administration.
2)Change in sitting BP (home BP before bedtime) between baseline values and values at the end of administration of Esaxerenone.
3)Proportion of patients achieving the target of sitting BP reduction.
4)Left Ventricular Mass (LVM) and Rate of change in left ventricular mass index (LVMI) between baseline and 12 weeks after the start of Esaxerenone administration.
5)Change in Left Ventricular posterior Wall Thickness (LVPWT), Relative Wall Thickness (RWT), the ratio between the E-wave velocity and A-wave velocity of the pulsed-wave Doppler mitral flow image (E/A), the ratio between E-wave velocity and the average early diastolic velocity of the lateral and septum at the mitral annulus level (E/e'), E-wave height, mitral annulus early diastolic velocity (e'), a', tricuspid regurgitation velocity (TRV), left atrial volume index (LAVI), left ventricular end-diastolic dimension (LVDd), deceleration time (DT), left ventricular ejection fraction (LVEF), vascular function test (baPWV or CAVI), myocardial strain, myocardial strain rate, left ventricular volume, left atrial volume,double product (DP), triple-product (TP), coefficient of variation of R-R Interval (CVR-R), NT-proBNP, CRP, PAC, PRA, and urinary (Na, K, albumin, creatinine, protein) between baseline and 12 weeks after the start of Esaxerenone administration.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Tsujita Kenichi
• Source(s) of Monetary Support: Daiichi Sankyo.Co., Ltd.