NCT06004453

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

Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care in Heart Failure Units and Independent Centers Utilizing Established Quality Indicators

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 899 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aimed 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 was imposed on participants to avoid interference with routine clinical care. HFrEF patients were treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data was collected as part of the study from patient files.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	Heart Failure medications	There was no treatment allocation. Patients were allocated to the respective cohort based on the treating physician enrolling them in the study. Patients were treated according to the local prescribing information and routine medical practice.

Timeline

• Start date: 2023-04-03
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2023-08-22
• Last updated: 2025-12-05

Locations

94 sites across 1 country: Germany