EAGLE-DH study

Not Applicable

• Conditions: Hypertension with diabetes; Diabetse, Hypertension

• Registration Number: JPRN-jRCTs031200273
• Lead Sponsor: Motoki Hirohiko

Brief Summary

In hypertensive patients with diabetes taking SGLT2 inhibitor with inadequate response to basal antihypertensive drug(s), esaxerenone significantly reduced BP and UACR, confirming the antihypertensive and renoprotective effects of esaxerenone. In the study, there was no serious adverse drug reaction, and no safety issue.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-25
• Study Completion: 2022-02-25
• Results First Posted: 2023-09-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 93

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 <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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change form baseline in blood pressure [home BP(before early morning medication): systolic BP, diastolic BP]in the sitting position

Secondary Outcome Measures

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