Applicability of past and ongoing steroidal and non-steroidal mineralocorticoid receptor antagonist trials in real-world patients with heart failure with reduced, mildly reduced, and preserved ejection fraction

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assessment of applicability of RCTs on MRA in a real-world HF population based on enrolment criteria
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C03DA01) spironolactone

  spironolactone

  (C03DA04) eplerenone

  eplerenone

  (C03DA05) finerenone

  finerenone
• Medical condition to be studied:
  Heart failure with reduced ejection fraction

  Heart failure with preserved ejection fraction
• Additional medical condition(s):
  Heart failure with mildly reduced ejection fraction

Population studied

• Short description of the study population:
  Real-world patients with heart failure in the Swedish Heart Failure Registry (SwedeHF) with a registration in 2017-2023.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Frail population

  Hepatic impaired

  Renal impaired

Study design details

• Study design:
  Cross-sectional study using Swedish quality registries in retrospect.
• Main study objective:
  We aim to assess the eligibility of a real-world HF population to past and ongoing MRA trials (RALES, TOPCAT, SPIRRIT-HFpEF, SPIRIT-HF, EMPHASIS-HF, FINEARTS-HF, FINALITY-HF, and REDEFINE-HF) to explore their generalisability, and to identify key inclusion and exclusion criteria to inform future trial design.
• Setting:
  Country: Sweden; Time: 2017-2023; Care setting: in-hospital & specialised outpatient care; Condition: all HF phenotypes