Last Update: Jun 14, 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.

Heart Failure
Recruiting
1250
Apr 04, 2023
Jan 01, 2025
All
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:

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

Study Location

Novartis Investigative Site

Recruiting

Biedenkopf,35216,Germany

Novartis Investigative Site

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Kaiserslautern,Rhineland-Palatinate,67655,Germany

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Dresden,01277,Germany

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Bad Vilbel,61118,Germany

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Gera,D 07551,Germany

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Brueel,19412,Germany

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Farchant,82490,Germany

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Biederitz OT Heyrothsberge,39175,Germany

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Kleinblittersdorf,Saarland,66271,Germany

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Dresden,01397,Germany

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Bechhofen,66894,Germany

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Giengen,89537,Germany

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Chemnitz,Saxony,09113,Germany

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Frankenthal,Pfalz,67227,Germany

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Bitterfeld,06749,Germany

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Ludwigsburg,Ossweil,71840,Germany

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Duesseldorf,40225,Germany

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Goeppingen,73033,Germany

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Berlin,10365,Germany

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Coburg,96450,Germany

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Frankfurt,60316,Germany

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Aichach,86551,Germany

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Pirna,Saxony,01796,Germany

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Braunschweig,Niedersachsen,38126,Germany

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Duessledorf,40217,Germany

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Hagen,58135,Germany

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Berlin,13053,Germany

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Coswig,06869,Germany

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Frankfurt,60590,Germany

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Amberg,92224,Germany

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Winsen,Lower Saxony,21423,Germany

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Breuberg,64747,Germany

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Duisburg,47051,Germany

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Halle S,06120,Germany

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Berlin,D 10559,Germany

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Dessau-Rosslau,06847,Germany

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Freiberg,09559,Germany

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Bad Homburg,61348,Germany

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Brilon,59929,Germany

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Ehingen,89584,Germany

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Hamburg,20095,Germany

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Bexbach,66450,Germany

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Dinkelsbuhl,91550,Germany

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Bad Neustadt,97616,Germany

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Fulda,36037,Germany

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Bruchsal,76646,Germany

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Erfurt,99097,Germany

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