Clinical trial NCT06004453: Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care
Official title: Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care in Heart Failure Units and Independent Centers Utilizing Established Quality Indicators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
HFrEF
patient management
quality of care
quality indicators
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 899
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure with reduced ejection fraction patients with a recent decompensation event

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of sites with a dedicated multidisciplinary team to manage patients with HF
timeFrame: Baseline
measure: Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.
timeFrame: Baseline
measure: (A) Proportion of patients with HF who have a documentation of their HF clinical type
timeFrame: Baseline
measure: (B) Proportion of patients with a documentation of their electrocardiogram findings
timeFrame: 6 months
measure: (C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)
timeFrame: 3 months
measure: (D) Proportion of patients who have their blood tests documented
timeFrame: 3 months
measure: (E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program
timeFrame: 6 months
measure: (F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge
timeFrame: 4 weeks
measure: (G) Proportion of patients treated with beta-blocker bisoprolol, carvedilol, sustained-release metoprolol succinate, or nebivolol in the absence of any contraindications as defined by Aktaa et al 2022
timeFrame: 6 months
measure: (H) Proportion of patients treated with an Angiotensin-converting enzymes (ACE) inhibitor, Angiotensin receptor blocker (ARB) or Angiotensin receptor-neprilysin inhibitor (ARNI) in the absence of any contraindications
timeFrame: 6 months
measure: (I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications
timeFrame: 6 months
measure: (J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications
timeFrame: 6 months
measure: Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment
timeFrame: 6 months
measure: Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention
timeFrame: 6 months
measure: Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together
timeFrame: 6 months
measure: Percentage of days covered with all four treatment classes
timeFrame: 6 months
measure: (K) Proportion of symptomatic patients with HFrEF in sinus rhythm with a QRS duration ≥150ms and left bundle branch block QRS morphology and with LVEF ≤35% despite ≥3 months optimal medical therapy who are offered cardiac resynchronization therapy
timeFrame: 6 months
measure: (L) Proportion of symptomatic patients with HF, LVEF ≤35% despite ≥3 months of optimal medical therapy, and ischemic heart disease (IHD) who are offered primary prevention implantable cardioverter defibrillator
timeFrame: 6 months
measure: Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool
timeFrame: 6 months
measure: Number of patients who are eligible for and have accomplished secondary endpoint g-j divided by the number of patients who are eligible for g-j
timeFrame: 6 months
measure: Number of HF hospitalizations, stratified by bed type
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 6 months
measure: Number of HF hospitalizations per patient
timeFrame: 6 months
measure: Number of newly implanted devices
timeFrame: 6 months
measure: Number of valve interventions
timeFrame: 6 months
measure: Number of participants with medical history of selected comorbidities
timeFrame: Baseline
Other outcomes:
Locations:
city: Winsen
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Ludwigsburg
country: Germany
facility: Novartis Investigative Site
state: Ossweil
city: Frankenthal
country: Germany
facility: Novartis Investigative Site
state: Pfalz
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
state: Rhineland-Palatinate
city: Kleinblittersdorf
country: Germany
facility: Novartis Investigative Site
state: Saarland
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
state: Saxony
city: Pirna
country: Germany
facility: Novartis Investigative Site
state: Saxony
city: Aichach
country: Germany
facility: Novartis Investigative Site
city: Amberg
country: Germany
facility: Novartis Investigative Site
city: Bad Homburg
country: Germany
facility: Novartis Investigative Site
city: Bad Neustadt
country: Germany
facility: Novartis Investigative Site
city: Bad Vilbel
country: Germany
facility: Novartis Investigative Site
city: Bechhofen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bexbach
country: Germany
facility: Novartis Investigative Site
city: Biedenkopf
country: Germany
facility: Novartis Investigative Site
city: Bitterfeld
country: Germany
facility: Novartis Investigative Site
city: Breuberg
country: Germany
facility: Novartis Investigative Site
city: Brilon
country: Germany
facility: Novartis Investigative Site
city: Bruchsal
country: Germany
facility: Novartis Investigative Site
city: Brueel
country: Germany
facility: Novartis Investigative Site
city: Coburg
country: Germany
facility: Novartis Investigative Site
city: Coswig
country: Germany
facility: Novartis Investigative Site
city: Dessau-Rosslau
country: Germany
facility: Novartis Investigative Site
city: Dinkelsbuhl
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Duessledorf
country: Germany
facility: Novartis Investigative Site
city: Ehingen
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Farchant
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiberg
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Giengen
country: Germany
facility: Novartis Investigative Site
city: Goeppingen
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Halle S
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Homburg
country: Germany
facility: Novartis Investigative Site
city: Hoppegarten
country: Germany
facility: Novartis Investigative Site
city: Ingelheim
country: Germany
facility: Novartis Investigative Site
city: Jerichow
country: Germany
facility: Novartis Investigative Site
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Kitzingen
country: Germany
facility: Novartis Investigative Site
city: Kleve
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Limbach-Oberfrohna
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Luebeck
country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Wittenberg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Markkleeberg
country: Germany
facility: Novartis Investigative Site
city: Moers
country: Germany
facility: Novartis Investigative Site
city: Muellheim
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Papenburg
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Radebeul
country: Germany
facility: Novartis Investigative Site
city: Rastatt
country: Germany
facility: Novartis Investigative Site
city: Remscheid
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Rotenburg an der Fulda
country: Germany
facility: Novartis Investigative Site
city: Rudersberg
country: Germany
facility: Novartis Investigative Site
city: Schoenebeck
country: Germany
facility: Novartis Investigative Site
city: Schwandorf
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Speyer
country: Germany
facility: Novartis Investigative Site
city: Stadtlohn
country: Germany
facility: Novartis Investigative Site
city: Stahnsdorf
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Urbach
country: Germany
facility: Novartis Investigative Site
city: Wedemark
country: Germany
facility: Novartis Investigative Site
city: Wermsdorf
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Winsen
country: Germany
facility: Novartis Investigative Site
city: Wismar
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: