Investigation on the Impact of Finerenone on Myocardial Remodeling in Patients With Diabetic Kidney Disease and Heart Failure

Korábbi kezelés

• 2. **Recent Cardiovascular Events (within 90 days prior to enrollment):**
• Coronary artery bypass graft (CABG) surgery or Percutaneous Coronary Intervention (PCI).
• Severe COPD requiring home oxygen therapy or chronic oral steroid therapy.
• Peripartum, chemotherapy-induced, viral, or infiltrative cardiomyopathy.
• 6. **Surgery and Acute Support:**
• 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:**
• Previous or continuous use (≥ 90 days) of MRAs within 12 months prior to enrollment.
• Concurrent use of strong CYP3A4 inhibitors or moderate/strong CYP3A4 inducers within 7 days prior to enrollment.
• Participation in other interventional clinical trials within 30 days prior to enrollment.
• Current alcohol or illicit drug abuse.

Más betegség

• Acute inflammatory heart disease (e.g., acute myocarditis).
• Stroke or Transient Ischemic Attack (TIA).
• 3. **Comorbidities Mimicking Heart Failure:**
• Primary pulmonary hypertension.
• Clinically significant valvular heart disease.
• 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).
• Right heart failure not caused by left heart failure.
• Planned surgery for heart failure-related etiologies (e.g., severe AS or MR).
• History of hyperkalemia or acute renal failure resulting in discontinuation of MRA treatment lasting more than 7 days.
• Known hypersensitivity to Finerenone or its excipients.
• Hepatic impairment classified as Child-Pugh C.
• Addison's disease (primary adrenocortical insufficiency).
• Life expectancy < 12 months (e.g., active malignancy).

Laborértékek

• 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).
• Myocardial infarction or any event likely to reduce ejection fraction.
• Hemoglobin < 10 g/dL.
• Inability to discontinue renin inhibitors or potassium-sparing diuretics (other than Finerenone).

Egyéb

• 1. **Renal and Electrolyte Stability:**
• Body Mass Index (BMI) > 50 kg/m².
• 4. **Hemodynamic and Rhythm Instability:**
• Symptomatic hypotension or mean SBP < 90 mmHg.
• 5. **Specific Cardiomyopathies and Devices:**
• Constrictive pericarditis or hereditary hypertrophic cardiomyopathy.
• Use of a Left Ventricular Assist Device (LVAD).
• 8. **General Health and Other Exclusions:**
• Pregnant or breastfeeding women.
• Close relationship with the study site or investigators.
• Legal detention or incarceration.

• 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.