ESPIAL TRIAL

JRCT ID: jRCTs051210066

Registered date:17/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: hypertension
• Date of first enrollment: 08/02/2022
• Target sample size: 110
• Study type: Interventional

Intervention(s)

(investigational treatment) Esaxerenone in addition to standard of care treatment (ACE-I or ARBs) according to approved usage and dose
(Control treatment) Amlodipine in addition to standard of care treatment (ACE-I or ARBs) according to approved usage and dose

Outcome(s)

• Primary Outcome: The ratio of UACR before the treatment and 24 weeks after the treatment

Secondary Outcome

(1) The ratio of UACR before the treatment and 48 weeks after the treatment
(2) Changes in The ratio of UACR over time before the treatment and after the treatment (until 48 weeks after the treatment)
(3) Changes in UACR over time after the treatment (until 48 weeks after the treatment)
(4) Patient proportion of normo-, micro- or macro-albuminuria classification (until 48 weeks after the treatment)
(5) Patient proportion of improved, unchanged or worsen in albuminuria classification (24 weeks after the treatment)
(6) Changes in Office Blood Pressure (24 weeks and 48 weeks after the treatment)
(7) Changes in eGFR over time after the treatment (24 weeks and 48 weeks after the treatment)
(8) Changes in the ratio of eGFR over time before the treatment and after the treatment (24 weeks and 48 weeks after the treatment)
(9) Changes in Urinary Beta2-microglobulin (24 weeks and 48 weeks after the treatment)
(10) Changes in Urinary NGAL (24 weeks after the treatment)
(11) Changes in serum cystatin C (24 weeks after the treatment)
(12) Changes in serum NT-proBNP concentration (24 weeks and 48 weeks after the treatment)
(13) Changes in plasma aldosterone concentration (24 weeks after the treatment)
(14) Changes in plasma renin activity (24 weeks after the treatment)
(15) Changes in plasma arginine vasopressin (24 weeks after the treatment)
(16) Time to the occurrence of the composite endpoints (Cardiac death or re-hospitalization due to heart failure)
(17) Time to the occurrence of the composite endpoints (Cardiac death or re-hospitalization due to cardiovascular disease)
(18) Time to the occurrence of cardiac death
(19) Time to the occurrence of re-hospitalization due to any cause
(20) Time to the occurrence of re-hospitalization due to cardiovascular disease
(21) Time to the occurrence of re-hospitalization due to heart failure
(22) Time to the occurrence of the composite endpoints (non-fatal MI or non-fatal stroke and all cause death)
(23) Time to the occurrence of non-fatal MI
(24) Time to the occurrence of non-fatal stroke
(25) Time to the occurrence of all cause death
(26) Time to the occurrence of sudden death
(27) Changes in NYHA cardiac function class (24 weeks and 48 weeks after the treatment)
(28) Changes in left ventricular ejection fraction measured by echocardiography (24 weeks and 48 weeks after the treatment)
(29) Changes in left ventricular end diastolic diameter measured by echocardiography (24 weeks and 48 weeks after the treatment)
(30) Changes in left ventricular mass index measured by echocardiography (24 weeks and 48 weeks after the treatment)
(31) Changes in left atrium diameter measured by echocardiography (24 weeks and 48 weeks after the treatment)
(32) Changes in left atrium volume measured by echocardiography (24 weeks and 48 weeks after the treatment)
(33) Changes in e' measured by echocardiography (24 weeks and 48 weeks after the treatment)
(34) Changes in E/e' measured by echocardiography (24 weeks and 48 weeks after the treatment)
(35) Changes in TRPG measured by echocardiography (24 weeks and 48 weeks after the treatment)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

(1) Patients aged from 20 to 90 years
(2) Patients diagnosed with hypertension
(3) Patients diagnosed with heart failure
(4) Patients who has UACR of more than 30mg/gCre
(5) Use of ACE-I, ARB, or conpounds containing these
(6) Patients who are capable of providing written consent

Exclude criteria

(1) Use of MRA for more than 7 days in the past 3 month
(2) Use of Amlodipine at maximum dose
(3) Patients with serum potassium level >5.0mmol/L
(4) Patients are on potassium supplementation
(5) Patients with renal impairment with an eGFR <30 mL/min/1.73m2
(6) Patients with hepatic dysfunction with AST or ALT 3-fold of upper limit of normal
(7) Patients initiated with SGLT2 inhibitor within a month before the consent
(8) Patients who are pregnant, possibly pregnant, or breast feeding
(9) Patients who have been enrolled in other clinical studies at the same time with this study
(10) Patients who are judged by the investigator or subinvestigators to be not suitable for participation in the study

Related Information

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