NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031200273

Registered date:25/12/2020

EAGLE-DH study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHypertension with diabetes
Date of first enrollment07/01/2021
Target sample size90
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Orally administer Esaxerenone once a day according to package insert. Start administration of Esaxerenone 2.5mg and if the effect is insufficient, the dose can be increased to 5 mg. Patients with moderate renal dysfunction (eGFRcreat is 30 or more and less than 60 mL.min/1,73m2) and albuminuria or diabetes with proteinuria start administration of Esaxerenone 1.25 mg, and the dose is increased to 2.5 mg after 4th week of the administration period, depending on the condition of the patient such as serum potassium level. If the effect is insufficient, the dose can be increased to 5 mg.

Outcome(s)

Primary OutcomeChange form baseline in blood pressure [home BP(before early morning medication): systolic BP, diastolic BP]in the sitting position
Secondary Outcome1, Efficacy 1) Change form baseline in blood pressure [office BP and home BP (bedtime): systolic BP, diastolic BP]in the sitting position 2) Transition of change from baseline in blood pressure [office BP and home BP (before early morning medication and bedtime): systolic BP, diastolic BP and mean BP]in the sitting position 3) Achievement ratio of target BP levels 4) Change from baseline in UACR 5) Change form baseline in serum NT-proBNP and CRP 6) Change form baseline in HbA1c 7) Change form baseline in plasma renin activity and plasma aldosterone 8) Change form baseline in urinary marker (Na, K, Na/K ratio, L-FABP, NAG, Beta2-MG, 8-OHdG) 2, Safety 1) Incidence of adverse events 2) Changes in eGFRcreat, amount of change and rate of change 3) Percentage of study subjects with serum potassium levels:5.5 mEq/L or more, 6.0 mEq/L or more 4) Change in serum potassium 5) Changes in pulse rate, amount of change

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) Patients aged 20 years or older 2) Patients with type 2 diabetes 3) Patients treated oral hypoglycemic drugs (one SGLT2 inhibitor, one SGLT2 inhibitor + one other oral hypoglycemic drug combination, or one SGLT2 inhibitor + two other oral hypoglycemic drug combination) at a fixed dosage 4) Patients treated basal antihypertensive drugs (one RAS inhibitor, one Ca channel blocker, or one RAS inhibitor + one Ca channel blocker) 5) Patients with hypertension (early morning home blood pressure [BP]: =>125 mmHg and <160 mmHg of systolic blood pressure and/or =>75 mmHg and <100 mmHg of diastolic blood pressure) 6) Patients whose eGFRcreat (mL/min/1.73 m2) is 30 or more 7) Patients who can measure home blood pressure
Exclude criteria1) Patients diagnosed with secondary hypertension or patients with malignant hypertension 2) Patients treated insulin and GLP-1 receptor agonist 3) Patients with nephrotic syndrome 4) Hyperkalemia patients, patients whose serum potassium level exceeds 5.0 mEq/L 5) Patients with any cerebro-cardiovascular diseases 6) Patients had NYHA class IV 7) Patients treated contraindication medicine specified in this study within 4 weeks prior to enrollment 8) Patients with severe liver dysfunction (liver failure, cirrhosis, etc.) 9) Patients diagnosed with life expectancy within one year due to some disease 10) Patients with a history of serious drug allergy 11) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant 12) Patients who are inappropriate for this study judged by their primary physicians

Related Information

Contact

Public contact
Name Hirohiko Motoki
Address Asahi 3-1-1, Matsumoto, Nagano, JAPAN Nagano Japan 390-8621
Telephone +81-263-37-3486
E-mail hmotoki@shinshu-u.ac.jp
Affiliation Department of Cardiovascular Medicine, Shinshu University School of Medicine
Scientific contact
Name Hirohiko Motoki
Address Asahi 3-1-1, Matsumoto, Nagano, JAPAN Nagano Japan 390-8621
Telephone +81-263-37-3486
E-mail hmotoki@shinshu-u.ac.jp
Affiliation Department of Cardiovascular Medicine, Shinshu University School of Medicine