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

Last Update: Jan 09, 2024

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

ClinicalTrials.gov Identifier:

NCT06004453

Novartis Reference Number:CLCZ696BDE06

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

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.

Condition

Heart Failure

Overall Status

Recruiting

Number of Participants

1250

Start Date

Apr 05, 2023

Completion Date

Jan 01, 2025

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

Heart Failure medications

There is no treatment allocation. Patients are allocated to the respective cohort based on the treating physician enrolling them in the study. Patients are treated according to the local prescribing information and routine medical practice.

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Location

Novartis Investigative Site

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Peine,31224,Germany

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Bad Neustadt,97616,Germany

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Halle S,06120,Germany

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Siegen,57072,Germany

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Chemnitz,Saxony,09113,Germany

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Kiel,24105,Germany

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Frankfurt,60590,Germany

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Muellheim,79379,Germany

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Wuerzburg,97080,Germany

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Rostock,18107,Germany

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Biedenkopf,35216,Germany

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Hoyerswerda,02977,Germany

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Urbach,99765,Germany

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Ehingen,89584,Germany

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Lübeck,23569,Germany

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Hamburg,20095,Germany

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Penzberg,82377,Germany

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Bad Vilbel,61118,Germany

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Speyer,67346,Germany

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Coburg,96450,Germany

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Kiel,24106,Germany

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Freiberg,09559,Germany

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Muenster,48149,Germany

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Rotenburg an der Fulda,36199,Germany

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Biederitz OT Heyrothsberge,39175,Germany

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Ingelheim,55218,Germany

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Wedemark,30900,Germany

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Ehringshausen,35630,Germany

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Hamburg,22087,Germany

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Pirna,Saxony,01796,Germany

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Bechhofen,66894,Germany

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Stadtbergen,86391,Germany

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Dessau-Rosslau,06847,Germany

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Kitzingen,97318,Germany

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Gera,D 07551,Germany

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Nuernberg,90461,Germany

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Aichach,86551,Germany

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Jerichow,39319,Germany

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Rudersberg,73635,Germany

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Braunschweig,Niedersachsen,38126,Germany

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Wenden,57482,Germany

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Erfurt,99097,Germany

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Ludwigshafen,67067,Germany

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Heidelberg,69115,Germany

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Potsdam,14471,Germany

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Berlin,10365,Germany

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Leer,26789,Germany

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Stadtlohn,48703,Germany

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Dinkelsbuhl,91550,Germany

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Giengen,89537,Germany

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Oberhausen,46149,Germany

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Amberg,92224,Germany

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Kaiserslautern,67657,Germany

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Saarlouis,66740,Germany

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Breuberg,64747,Germany

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Winsen,Lower Saxony,21423,Germany

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Farchant,82490,Germany

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Lutherstadt Wittenberg,06886,Germany

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Heidelberg,69120,Germany

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Radebeul,01445,Germany

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Berlin,13053,Germany

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Leipzig,04209,Germany

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Stahnsdorf,14532,Germany

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Dresden,01277,Germany

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Augsburg,86163,Germany

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Goeppingen,73033,Germany

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Osnabrueck,49074,Germany

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Kaiserslautern,Rhineland-Palatinate,67655,Germany

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Schoenebeck,39218,Germany

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Brilon,59929,Germany

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Markkleeberg,04416,Germany

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Frankenthal,Pfalz,67227,Germany

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Berlin,D 10559,Germany

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Homburg,66421,Germany

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Rastatt,76437,Germany

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Limbach-Oberfrohna,09212,Germany

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Stuttgart,70376,Germany

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Dresden,01397,Germany

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Papenburg,26871,Germany

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Bad Homburg,61348,Germany

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Hagen,58135,Germany

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Brueel,19412,Germany

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Kassel,34121,Germany

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Schwandorf,92421,Germany

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Moers,47441,Germany

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Wismar,23966,Germany

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Frankfurt,60316,Germany

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Remscheid,42859,Germany

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Bexbach,66450,Germany

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Hoppegarten,15366,Germany

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Duesseldorf,40225,Germany

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Loehne,32584,Germany

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Ulm,89077,Germany

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