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

NCT06004453 | Completed

• 1 other identifier: CLCZ696BDE06
• Study Type: observational
• Target: 899
• Locations: 1 country
• Sites: 94

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart Failure; HFrEF; patient management; quality of care; quality indicators

Outcome Measures

Primary Outcomes (1)

• Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint

  Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based QI composite endpoint defined by the number of times each of secondary endpoints has been accomplished divided by chances to accomplish them as average per center type. To describe the quality of Heart Failure (HF) patient care in Heart Failure Unit (HFU) and non-HFU centers utilizing QIs as suggested by the 2021 European Society of Cardiology HF guideline.

  6 months

Secondary Outcomes (26)

• Proportion of sites with a dedicated multidisciplinary team to manage patients with HF

  Baseline

• Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.

  Baseline

• (A) Proportion of patients with HF who have a documentation of their HF clinical type

  Baseline

• (B) Proportion of patients with a documentation of their electrocardiogram findings

  6 months

• (C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)

  3 months

Study Arms (5)

Cohort A

Supra-regional HFU Centers and HFU Focus Hospitals

Other: Heart Failure medications

Cohort B

Non-HFU Hospitals

Other: Heart Failure medications

Cohort C

HFU Residential Cardiologists

Other: Heart Failure medications

Cohort D

Non-HFU Residential Cardiologists

Other: Heart Failure medications

Cohort E

General practitioners

Other: Heart Failure medications

Interventions

Heart Failure medications 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 A; Cohort B; Cohort C; Cohort D; Cohort E

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure with reduced ejection fraction patients with a recent decompensation event

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (94)

Novartis Investigative Site

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Novartis Investigative Site

Ludwigsburg, Baden-Wurttemberg, 71640, Germany

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Muellheim Im Markgraeflerland, Baden-Wurttemberg, 79379, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Kassel, Hesse, 34121, Germany

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Braunschweig, Lower Saxony, 38126, Germany

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Winsen, Lower Saxony, 21423, Germany

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Löhne, North Rhine-Westphalia, 32584, Germany

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Frankenthal, Rhineland-Palatinate, 67227, Germany

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Ingelheim, Rhineland-Palatinate, 55218, Germany

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Kaiserslautern, Rhineland-Palatinate, 67655, Germany

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Kaiserslautern, Rhineland-Palatinate, 67657, Germany

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Kleinblittersdorf, Saarland, 66271, Germany

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Chemnitz, Saxony, 09113, Germany

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Leipzig, Saxony, 04209, Germany

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Limbach-Oberfrohna, Saxony, 09212, Germany

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Pirna, Saxony, 01796, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Jerichow, Saxony-Anhalt, 39319, Germany

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Berlin, State of Berlin, 10365, Germany

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Gera, Thuringia, 07551, Germany

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Aichach, 86551, Germany

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Amberg, 92224, Germany

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Bad Homburg, 61348, Germany

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Bad Neustadt an der Saale, 97616, Germany

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Bad Vilbel, 61118, Germany

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Bechhofen, 66894, Germany

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Berlin, 10559, Germany

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Berlin, 13053, Germany

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Bexbach, 66450, Germany

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Biedenkopf, 35216, Germany

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Bitterfeld-Wolfen, 06749, Germany

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Breuberg, 64747, Germany

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Brilon, 59929, Germany

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Bruchsal, 76646, Germany

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Brüel, 19412, Germany

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Coburg, 96450, Germany

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Coswig, 06869, Germany

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Dessau, 06847, Germany

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Dinkelsbühl, 91550, Germany

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Dresden, 01277, Germany

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Dresden, 01397, Germany

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Düsseldorf, 40217, Germany

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Düsseldorf, 40225, Germany

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Ehingen, 89584, Germany

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Erfurt, 99097, Germany

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Farchant, 82490, Germany

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Freiberg, 09559, Germany

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Fulda, 36037, Germany

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Giengen an der Brenz, 89537, Germany

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Göppingen, 73033, Germany

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Hagen, 58135, Germany

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Hamburg, 20095, Germany

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Hamburg, 22087, Germany

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Heidelberg, 69120, Germany

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Homburg, 66421, Germany

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Hoppegarten, 15366, Germany

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Kiel, 24105, Germany

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Kiel, 24106, Germany

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Kitzingen, 97318, Germany

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Kleve, 47533, Germany

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Leipzig, 04129, Germany

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Ludwigshafen, 67067, Germany

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Lübeck, 23569, Germany

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Magdeburg, 39120, Germany

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Markkleeberg, 04416, Germany

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Moers, 47441, Germany

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Münster, 48149, Germany

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Osnabrück, 49074, Germany

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Papenburg, 26871, Germany

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Potsdam, 14471, Germany

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Radebeul, 01445, Germany

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Rastatt, 76437, Germany

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Remscheid, 42859, Germany

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Rostock, 18107, Germany

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Rotenburg an der Fulda, 36199, Germany

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Rudersberg, 73635, Germany

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Schönebeck, 39218, Germany

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Schwandorf in Bayern, 92421, Germany

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Siegen, 57072, Germany

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Speyer, 67346, Germany

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Stadtlohn, 48703, Germany

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Stahnsdorf, 14532, Germany

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Stuttgart, 70376, Germany

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Ulm, 89077, Germany

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Urbach, 99765, Germany

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Wedemark, 30900, Germany

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Wermsdorf, 04779, Germany

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Wiesbaden, D-65199, Germany

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Winsen, 21423, Germany

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Wismar, 23966, Germany

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Wittenberg, 06886, Germany

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Novartis Investigative Site

Wolfsburg, 38440, Germany

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Novartis Investigative Site

Würzburg, 97080, Germany

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 22, 2023
• Study Start: April 3, 2023
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (94)