diabetic cardiovascular autonomic neuropathy
Conditions
Interventions
Placebo group:Placebo
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years. 2. Meet the diagnostic criteria for Diabetic Kidney Disease (DKD). 3. Meet the diagnostic criteria for Diabetic Cardiovascular Autonomic Neuropathy (DCAN), defined as a total score of >=2 points in the Cardiovascular Autonomic Reflex Tests (CART). 4. Glycated hemoglobin (HbA1c) <=10%. 5. Serum potassium level <=5.0 mmol/L. 6. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. eGFR 160 mmHg or diastolic blood pressure >100 mmHg). 3. Concurrent use of steroidal mineralocorticoid receptor antagonists (MRAs, e.g., spironolactone, eplerenone) or strong CYP3A4 inhibitors (e.g., ketoconazole), or long-term use of non-steroidal anti-inflammatory drugs (NSAIDs). 4. History of malignancy within the past 5 years. 5. Hepatic insufficiency, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >3 times the upper limit of normal. 6. Known hypersensitivity to finerenone. 7. Pregnancy or lactation. 8. History of psychiatric or psychological disorders, or any other condition that may compromise protocol compliance. 9. Any other circumstance considered by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CART score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Autonomic nervous system symptom score;UACR, eGFR, and blood potassium levels; TNF-a, IL-6, MDA, SOD; | — |
Countries
China
Contacts
Public ContactKong Feijuan
Shanghai General Hospital
Outcome results
None listed