Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care
NCT ID: NCT06004453
Last Updated: 2025-12-05
Study Results
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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COMPLETED
899 participants
OBSERVATIONAL
2023-04-03
2025-01-17
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
OTHER
Study Groups
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Cohort A
Supra-regional HFU Centers and HFU Focus Hospitals
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.
Cohort B
Non-HFU Hospitals
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.
Cohort C
HFU Residential Cardiologists
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.
Cohort D
Non-HFU Residential Cardiologists
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.
Cohort E
General practitioners
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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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
Countries
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Related Links
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Link to study results
Other Identifiers
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CLCZ696BDE06
Identifier Type: -
Identifier Source: org_study_id
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