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

NCT ID: NCT06004453

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

899 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-03

Study Completion Date

2025-01-17

Brief Summary

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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

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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

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort A

Supra-regional HFU Centers and HFU Focus Hospitals

Heart Failure medications

Intervention Type OTHER

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.

Cohort B

Non-HFU Hospitals

Heart Failure medications

Intervention Type OTHER

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.

Cohort C

HFU Residential Cardiologists

Heart Failure medications

Intervention Type OTHER

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.

Cohort D

Non-HFU Residential Cardiologists

Heart Failure medications

Intervention Type OTHER

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.

Cohort E

General practitioners

Heart Failure medications

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Heidelberg, Baden-Wurttemberg, Germany

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Ludwigsburg, Baden-Wurttemberg, Germany

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Muellheim Im Markgraeflerland, Baden-Wurttemberg, Germany

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Frankfurt am Main, Hesse, Germany

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Kassel, Hesse, Germany

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Braunschweig, Lower Saxony, Germany

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Winsen, Lower Saxony, Germany

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Löhne, North Rhine-Westphalia, Germany

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Frankenthal, Rhineland-Palatinate, Germany

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Ingelheim, Rhineland-Palatinate, Germany

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Kaiserslautern, Rhineland-Palatinate, Germany

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Kaiserslautern, Rhineland-Palatinate, Germany

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Kleinblittersdorf, Saarland, Germany

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Chemnitz, Saxony, Germany

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Leipzig, Saxony, Germany

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Limbach-Oberfrohna, Saxony, Germany

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Pirna, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Jerichow, Saxony-Anhalt, Germany

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Berlin, State of Berlin, Germany

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Gera, Thuringia, Germany

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Aichach, , Germany

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Amberg, , Germany

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Bad Homburg, , Germany

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Bad Neustadt an der Saale, , Germany

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Bad Vilbel, , Germany

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Bechhofen, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bexbach, , Germany

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Biedenkopf, , Germany

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Bitterfeld-Wolfen, , Germany

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Breuberg, , Germany

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Brilon, , Germany

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Bruchsal, , Germany

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Brüel, , Germany

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Coburg, , Germany

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Coswig, , Germany

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Dessau, , Germany

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Dinkelsbühl, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Düsseldorf, , Germany

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Ehingen, , Germany

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Erfurt, , Germany

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Farchant, , Germany

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Freiberg, , Germany

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Fulda, , Germany

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Giengen an der Brenz, , Germany

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Göppingen, , Germany

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Hagen, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Homburg, , Germany

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Hoppegarten, , Germany

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Kiel, , Germany

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Kiel, , Germany

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Kitzingen, , Germany

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Kleve, , Germany

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Leipzig, , Germany

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Ludwigshafen, , Germany

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Lübeck, , Germany

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Magdeburg, , Germany

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Markkleeberg, , Germany

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Moers, , Germany

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Münster, , Germany

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Osnabrück, , Germany

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Papenburg, , Germany

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Potsdam, , Germany

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Radebeul, , Germany

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Rastatt, , Germany

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Remscheid, , Germany

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Rostock, , Germany

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Rotenburg an der Fulda, , Germany

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Rudersberg, , Germany

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Schönebeck, , Germany

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Schwandorf in Bayern, , Germany

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Siegen, , Germany

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Speyer, , Germany

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Stadtlohn, , Germany

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Stahnsdorf, , Germany

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Stuttgart, , Germany

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Ulm, , Germany

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Urbach, , Germany

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Wedemark, , Germany

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Wermsdorf, , Germany

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Wiesbaden, , Germany

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Winsen, , Germany

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Wismar, , Germany

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Wittenberg, , Germany

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Wolfsburg, , Germany

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Würzburg, , Germany

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Countries

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Germany

Related Links

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Other Identifiers

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CLCZ696BDE06

Identifier Type: -

Identifier Source: org_study_id

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