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

Novartis

Status: Completed

Conditions: Heart Failure

Treatments: Other: Heart Failure medications

Study type: Observational

Funder types: Industry

Identifiers

NCT06004453

CLCZ696BDE06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 899 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

899 participants in 5 patient groups

Cohort A

Description:

Supra-regional HFU Centers and HFU Focus Hospitals

Treatment:

Other: Heart Failure medications

Cohort B

Description:

Non-HFU Hospitals

Treatment:

Other: Heart Failure medications

Cohort C

Description:

HFU Residential Cardiologists

Treatment:

Other: Heart Failure medications

Cohort D

Description:

Non-HFU Residential Cardiologists

Treatment:

Other: Heart Failure medications

Cohort E

Description:

General practitioners

Treatment:

Other: Heart Failure medications