CompletedNot Applicable

Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care

Germany899 participantsStarted 2023-04-03

Plain-language summary

This was a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient treatment and care following a decompensation event in different types of Heart Failure Unit (HFU) or non-HFU centers across Germany.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Patients who provide written informed consent to participate in the study
✓. Male or female patients ≥ 18 years of age
✓. Patients with diagnosis of heart failure with reduced ejection fraction (HFrEF) and HF treatment according to the summaries of product characteristics (SmPCs)
✓. Decompensation event up to three months prior to inclusion

Exclusion criteria

✕. Simultaneous or planned participation in an interventional research study
✕. Participation in this study at another site e.g. in a HFU network
✕. Patients incapable of understanding and signing the informed consent form

What they're measuring

Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint

Timeframe: 6 months

Trial details

NCT IDNCT06004453

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-17

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