Testing vicadrostat with empagliflozin against a placebo for heart failure

Inclusion

• +At least 18 years old and at least of the legal age of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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
• +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 randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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
• +Treated according to best possible standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → Further inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → apply.
• +Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth controlControl groupThe group a new treatment is measured against.Read more → 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