Hypertension with diabetes Diabetse, Hypertension
Conditions
Interventions
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 mode
Sponsors
Motoki Hirohiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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 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
Exclusion criteria
Exclusion criteria: 1) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change form baseline in blood pressure [home BP(before early morning medication): systolic BP, diastolic BP]in the sitting position | — |
Secondary
| Measure | Time frame |
|---|---|
| 1, 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 from baseline in plasma renin activity, plasma aldosterone concentration, and aldosterone-renin ratio 8) Change from baseline in urinary biomarker (Na, K, Na/K ratio, L-FABP, NAG, Beta2-MG, 8-OHdG) 2, Safety 1) Incidence of adverse events 2) Transition and amount of change in eGFRcreat 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 | — |
Contacts
Public ContactHirohiko Motoki
Department of Cardiovascular Medicine, Shinshu University School of Medicine
Outcome results
None listed