DIA 2024 - Redefining Excellence in Managing Patient Recruitment and Remote Data Collection
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Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care

Recruiting
18 - 100 years of age
Both
Phase N/A

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Overview

This is 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.

Description

This study aims to describe quality of care of HFrEF patients following a decompensation event in different center types (=settings) utilizing the quality indicators for the care and outcomes of adults with heart failure as specified by the Heart Failure Association in 2022.

No strict visit schedule will be imposed on participants to avoid interference with routine clinical care. HFrEF patients will be treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data will be collected as part of the study from patient files.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study details

Heart Failure

NCT06004453

Novartis Pharmaceuticals

15 June 2024

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