Semaglutide in patients with heart failure with reduced ejection fraction: safety and effectiveness – a target trial emulation

Study identification

• EU PAS number:
  EUPAS1000000809
• Study ID:
  1000000809
• Official title and acronym:
  Semaglutide in patients with heart failure with reduced ejection fraction: safety and effectiveness – a target trial emulation
• DARWIN EU® study:
  No
• Study countries:
  France

  Netherlands

  Portugal

  Sweden
• Study description:
  Efficacy and safety of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as semaglutide in patients with heart failure with reduced ejection fraction (HFrEF) remain unclear. Existing evidence is limited to post-hoc analyses or observational studies, often with uncertain validity of the HFrEF diagnosis. ; While the ongoing FIT-HF trial in HFrEF focuses on peak oxygen uptake as the primary outcome, no trial is currently addressing efficacy and safety. ; We aim to fill this gap by conducting a high-quality target trial emulation using the Swedish national quality and administrative registries.
• Study status:
  Planned

Research institutions and networks

Institutions

Radboud university medical center (Radboudumc)

Netherlands

Karolinska Institutet

Sweden

Centre for Research Epidemiology and Statistics (Paris, France)

Networks

More-EUROPA (Horizon Europe)

Study timelines

Date when funding contract was signed

Planned:07/04/2025

Actual:07/04/2025

Study start date

Planned:15/12/2025

Data analysis start date

Planned:02/01/2026

Date of final study report

Planned:30/06/2026

Sources of funding

EU institutional research programme

More details on funding

More Effectively Using Registries to suppOrt PAtient-centered Regulatory and HTA decision-making (More-EUROPA), Grant agreement ID: 101095479, Horizon Europe programme

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable