Heart-Healing hope: new drug targets damage in diabetic kidney patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. \*\*Age and Consent:\*\* * Age ≥ 18 years at the time of signing informed consent. * Capable of giving signed informed consent and willing to comply with all study requirements and restrictions. * 2\. \*\*Type 2 Diabetes and Chronic Kidney Disease (CKD):\*\* * Diagnosis of Type 2 Diabetes Mellitus with chronic kidney disease, defined by either: * Urine albumin-to-creatinine ratio (UACR) 30 to 300 mg/g AND estimated glomerular filtration rate (eGFR) 25 to 90 mL/min/1.73 m², OR * UACR ≥ 300 mg/g AND eGFR ≥ 60 mL/min/1.73 m². * 3\. \*\*Heart Failure Status:\*\* * Clinical diagnosis of Heart Failure (NYHA Class II to IV) currently receiving inpatient or outpatient treatment. * Diagnosis must be confirmed by meeting at least 2 \*\*Major Criteria\*\* OR 1 \*\*Major Criterion\*\* plus 2 \*\*Minor Criteria\*\* (Framingham Criteria): * \*\*Major Criteria:\*\* Orthopnea or paroxysmal nocturnal dyspnea; Jugular venous distension; Hepatojugular reflux; Pulmonary rales; Third heart sound (S3) gallop; Pulmonary edema; Cardiomegaly. * \*\*Minor Criteria:\*\* Decreased exercise tolerance; Night cough; Dependent (ankle) edema; Tachycardia (heart rate \> 120 bpm); Hepatomegaly; Pleural effusion. * 4\. \*\*Left Ventricular Function:\*\* * Documented Left Ventricular Ejection Fraction (LVEF) ≥ 40% measured by transthoracic echocardiography within the last 12 months. * 5\. \*\*Structural Heart Disease:\*\* * Confirmed by echocardiography, meeting at least one of the following findings: * LV mass index ≥ 95 g/m² in females or ≥ 115 g/m² in males. * Left atrial (LA) volume index \> 29 mL/m² (for sinus rhythm) or \> 40 mL/m² (for atrial fibrillation). * Average E/e' ratio \> 14. * Tricuspid regurgitation (TR) velocity \> 2.8 m/s. * 6\. \*\*Elevated Biomarkers:\*\* * Elevated NT-proBNP levels within 90 days prior to enrollment: * NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm. * NT-proBNP ≥ 600 pg/mL for participants with atrial fibrillation. * 7\. \*\*Reproductive Status:\*\* * Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception during the study. Exclusion Criteria: * 1\. \*\*Renal and Electrolyte Stability:\*\* * eGFR \< 25 mL/min/1.73 m² (One re-evaluation is permitted prior to enrollment). * Serum potassium \> 5.0 mmol/L at any screening or enrollment visit (One re-evaluation is permitted prior to enrollment). * 2\. \*\*Recent Cardiovascular Events (within 90 days prior to enrollment):\*\* * Acute inflammatory heart disease (e.g., acute myocarditis). * Myocardial infarction or any event likely to reduce ejection fraction. * Coronary artery bypass graft (CABG) surgery or Percutaneous Coronary Intervention (PCI). * Stroke or Transient Ischemic Attack (TIA). * 3\. \*\*Comorbidities Mimicking Heart Failure:\*\* * Severe COPD requiring home oxygen therapy or chronic oral steroid therapy. * Primary pulmonary hypertension. * Hemoglobin \< 10 g/dL. * Clinically significant valvular heart disease. * Body Mass Index (BMI) \> 50 kg/m². * 4\. \*\*Hemodynamic and Rhythm Instability:\*\* * Uncontrolled hypertension (SBP ≥ 160 mmHg on ≥ 3 drugs, or SBP ≥ 180 mmHg regardless of treatment). * Uncontrollable arrhythmia (Sustained VT, or AF/Flutter with resting HR \> 110 bpm). * Symptomatic hypotension or mean SBP \< 90 mmHg. * 5\. \*\*Specific Cardiomyopathies and Devices:\*\* * Peripartum, chemotherapy-induced, viral, or infiltrative cardiomyopathy. * Constrictive pericarditis or hereditary hypertrophic cardiomyopathy. * Right heart failure not caused by left heart failure. * Use of a Left Ventricular Assist Device (LVAD). * 6\. \*\*Surgery and Acute Support:\*\* * Planned surgery for heart failure-related etiologies (e.g., severe AS or MR). * Use of IV vasodilators, IV inotropes, or mechanical hemodynamic support (e.g., IABP, ECMO, mechanical ventilation) within 24 hours prior to enrollment. * 7\. \*\*Medication and Safety Concerns:\*\* * History of hyperkalemia or acute renal failure resulting in discontinuation of MRA treatment lasting more than 7 days. * Previous or continuous use (≥ 90 days) of MRAs within 12 months prior to enrollment. * Inability to discontinue renin inhibitors or potassium-sparing diuretics (other than Finerenone). * Concurrent use of strong CYP3A4 inhibitors or moderate/strong CYP3A4 inducers within 7 days prior to enrollment. * Known hypersensitivity to Finerenone or its excipients. * 8\. \*\*General Health and Other Exclusions:\*\* * Pregnant or breastfeeding women. * Hepatic impairment classified as Child-Pugh C. * Addison's disease (primary adrenocortical insufficiency). * Life expectancy \< 12 months (e.g., active malignancy). * Participation in other interventional clinical trials within 30 days prior to enrollment. * Close relationship with the study site or investigators. * Current alcohol or illicit drug abuse. * Legal detention or incarceration.