Resumen

Este estudio está abierto a adultos de 18 años o más de la edad legal con insuficiencia cardíaca. Las personas pueden unirse al estudio si tienen síntomas de insuficiencia cardíaca y una fracción de eyección del ventrículo izquierdo (FEVI) del 40% o más. El propósito de este estudio es determinar si vicadrostat (BI 690517) en combinación con empagliflozina ayuda a las personas con insuficiencia cardíaca. Los participantes se distribuyen en 2 grupos de forma aleatoria. Cada participante tiene igual probabilidad de ser asignado a cada grupo. Los grupos son: * Grupo vicadrostat/empagliflozina: los participantes toman vicadrostat/empagliflozina en comprimidos una vez al día. * Grupo placebo/empagliflozina: los participantes toman placebo/empagliflozina en comprimidos una vez al día. Los participantes pueden permanecer en el estudio mientras se beneficien del tratamiento y puedan tolerarlo. Durante este tiempo, visitan a sus médicos con regularidad. Los médicos verifican regularmente la salud de los participantes y registran cualquier efecto no deseado. El personal del estudio también puede comunicarse con los participantes por teléfono. Los participantes también responden periódicamente preguntas sobre su bienestar. El estudio no tiene una duración fija. Continúa hasta que haya datos suficientes para determinar si el tratamiento está funcionando.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information
Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2
Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:
in participants with body mass index (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
At least one of the following:
Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
Documented hospitalisation for HF within 6 months prior to Visit 1
Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1
in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1

Criterios de exclusión

Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study
Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator
Receiving the following treatments:
a direct renin inhibitor (e.g. aliskiren) at Visit 2
more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2
In case of acute decompensated HF:
i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)
i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery/CABG)
Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2
Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2

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