Effect of Finerenone on Myocardial Fibrosis and Cardiac Function in HFmrEF/HFpEF Patients

Laborértékek

• 1. eGFR <25 mL/min/1.73 m² at screening or enrollment. 2. Serum potassium concentration ≥5.0 mmol/L at screening or enrollment. 3. Prior confirmed diagnosis of HFrEF. 4. Acute inflammatory heart disease (e.g., acute myocarditis). 5. Acute myocardial infarction or other event likely to have reduced LVEF within 30 days prior to randomization.
  • Coronary artery bypass grafting within 30 days prior to randomization. 7. Percutaneous coronary intervention within 30 days prior to randomization. 8. History of stroke or transient ischemic attack (TIA) within 90 days prior to randomization.
  • Conditions where the investigator considers the primary cause of dyspnea (and thus heart failure symptoms) to be severe pulmonary disease, anemia, or obesity. Specific exclusions include: severe pulmonary disease requiring home oxygen therapy or long-term oral steroids; history of primary pulmonary hypertension; hemoglobin <100 g/L; severe valvular heart disease; BMI ≥50 kg/m².
  • Systolic blood pressure (SBP) >160 mmHg despite combination therapy with 3 antihypertensive drugs, OR SBP >180 mmHg on any treatment measured on (two consecutive occasions at least 2 minutes apart).
  • Severe malignant ventricular arrhythmia or atrial fibrillation with resting ventricular rate >100 bpm.
  • Symptomatic hypotension with mean SBP <90 mmHg. 13. Any HF condition requiring surgical intervention (e.g., severe aortic stenosis or mitral regurgitation).
  • History of peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, primary right ventricular cardiomyopathy, constrictive pericarditis, hereditary hypertrophic cardiomyopathy, or infiltrative cardiomyopathy (including amyloidosis).
  • Contraindications to CMR (e.g., magnetic metal implants, claustrophobia, contrast allergy).
  • History of hyperkalemia or acute renal failure during prior MRA therapy. 17. Known allergy or severe adverse reaction to finerenone. 18. History of severe hepatic impairment (Child-Pugh C). 19. Requirement for any intravenous inotropic drugs or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) within 24 hours prior to randomization.
  • Current or prior use (within 4 weeks before screening) of any MRA (e.g., spironolactone, eplerenone, canrenone, esaxerenone).
  • Use of renin inhibitors or potassium-sparing diuretics prior to randomization that cannot be discontinued.
  • Severe comorbidities (e.g., malignancy, lymphoma, cirrhosis, HIV-positive) with life expectancy <2 years.
  • Pregnancy, lactation, or planning pregnancy. Women of childbearing potential must have a negative serum pregnancy test pre-treatment, agree to serum/urine pregnancy tests at study visits (Months 3 and 6), and commit to using highly effective contraception during the study and for 3 months after. Male participants with female partners of childbearing potential must also agree to use highly effective contraception during the study and for 3 months after.
  • Participation in another clinical trial within 3 months prior to this study.
  • Any condition, in the investigator's judgment, that would preclude safe study participation or protocol compliance.

• Aged 18 to 80 years (inclusive), any gender.
• Symptomatic heart failure (NYHA class II-IV).
• Emergency department visit or hospitalization for HF within the past 3 months, or escalation of intravenous or oral diuretic therapy for worsening HF within the past 3 months.
• LVEF ≥40% measured by echocardiography or CMR within the past 30 days prior to screening.
• NT-proBNP ≥300 pg/mL for patients in sinus rhythm; NT-proBNP ≥900 pg/mL for patients with atrial fibrillation.
• Presence of myocardial fibrosis, defined as ECV ≥27% measured by CMR at baseline.
• Capable of providing voluntary written informed consent.