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

Heart Failure Clinical Trial

— CONNECT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004453
• Other study ID #: CLCZ696BDE06
• Status: Recruiting
• Start date: April 4, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aichach
Germany	Novartis Investigative Site	Amberg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Homburg
Germany	Novartis Investigative Site	Bad Neustadt
Germany	Novartis Investigative Site	Bad Vilbel
Germany	Novartis Investigative Site	Bechhofen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bexbach
Germany	Novartis Investigative Site	Biedenkopf
Germany	Novartis Investigative Site	Biederitz OT Heyrothsberge
Germany	Novartis Investigative Site	Bitterfeld
Germany	Novartis Investigative Site	Braunschweig	Niedersachsen
Germany	Novartis Investigative Site	Breuberg
Germany	Novartis Investigative Site	Brilon
Germany	Novartis Investigative Site	Bruchsal
Germany	Novartis Investigative Site	Brueel
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz	Saxony
Germany	Novartis Investigative Site	Coburg
Germany	Novartis Investigative Site	Coswig
Germany	Novartis Investigative Site	Dessau-Rosslau
Germany	Novartis Investigative Site	Dinkelsbuhl
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Duessledorf
Germany	Novartis Investigative Site	Duisburg
Germany	Novartis Investigative Site	Ehingen
Germany	Novartis Investigative Site	Ehringshausen
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Farchant
Germany	Novartis Investigative Site	Frankenthal	Pfalz
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiberg
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Giengen
Germany	Novartis Investigative Site	Goeppingen
Germany	Novartis Investigative Site	Hagen
Germany	Novartis Investigative Site	Halle S
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Hoppegarten
Germany	Novartis Investigative Site	Hoyerswerda
Germany	Novartis Investigative Site	Ingelheim
Germany	Novartis Investigative Site	Jerichow
Germany	Novartis Investigative Site	Kaiserslautern
Germany	Novartis Investigative Site	Kaiserslautern	Rhineland-Palatinate
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Kitzingen
Germany	Novartis Investigative Site	Kleinblittersdorf	Saarland
Germany	Novartis Investigative Site	Kleve
Germany	Novartis Investigative Site	Lahnau
Germany	Novartis Investigative Site	Lahr
Germany	Novartis Investigative Site	Leer
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Limbach-Oberfrohna
Germany	Novartis Investigative Site	Loehne
Germany	Novartis Investigative Site	Ludwigsburg	Ossweil
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Luebeck
Germany	Novartis Investigative Site	Lutherstadt Wittenberg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Markkleeberg
Germany	Novartis Investigative Site	Moers
Germany	Novartis Investigative Site	Muellheim
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Oberhausen
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Papenburg
Germany	Novartis Investigative Site	Peine
Germany	Novartis Investigative Site	Penzberg
Germany	Novartis Investigative Site	Pirna	Saxony
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Radebeul
Germany	Novartis Investigative Site	Rastatt
Germany	Novartis Investigative Site	Remscheid
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Rotenburg an der Fulda
Germany	Novartis Investigative Site	Rudersberg
Germany	Novartis Investigative Site	Saarlouis
Germany	Novartis Investigative Site	Schoenebeck
Germany	Novartis Investigative Site	Schwandorf
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Speyer
Germany	Novartis Investigative Site	Stadtbergen
Germany	Novartis Investigative Site	Stadtlohn
Germany	Novartis Investigative Site	Stahnsdorf
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Urbach
Germany	Novartis Investigative Site	Wedemark
Germany	Novartis Investigative Site	Wenden
Germany	Novartis Investigative Site	Wermsdorf
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Winsen
Germany	Novartis Investigative Site	Winsen	Lower Saxony
Germany	Novartis Investigative Site	Wismar
Germany	Novartis Investigative Site	Wolfsburg
Germany	Novartis Investigative Site	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of sites with a dedicated multidisciplinary team to manage patients with HF	To describe the structural framework of the participating centers.	Baseline
Secondary	Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.	To describe the structural framework of the participating centers.	Baseline
Secondary	(A) Proportion of patients with HF who have a documentation of their HF clinical type	HF clinical type: Heart failure with reduced ejection fraction (HFrEF), HF with a midrange ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF).; To describe the patient assessment in different types of HFU and non-HFU centers.	Baseline
Secondary	(B) Proportion of patients with a documentation of their electrocardiogram findings	To describe the patient assessment in different types of HFU and non-HFU centers.	6 months
Secondary	(C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)	To describe the patient assessment in different types of HFU and non-HFU centers.	3 months
Secondary	(D) Proportion of patients who have their blood tests documented	To describe the patient assessment in different types of HFU and non-HFU centers.	3 months
Secondary	(E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program	To describe the patient assessment in different types of HFU and non-HFU centers.	6 months
Secondary	(F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge	To describe the patient assessment in different types of HFU and non-HFU centers.	4 weeks
Secondary	(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	To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.	6 months
Secondary	(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	To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.	6 months
Secondary	(I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications	To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.	6 months
Secondary	(J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications	To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.	6 months
Secondary	Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment	To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.	6 months
Secondary	Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention	To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.	6 months
Secondary	Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together	To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.	6 months
Secondary	Percentage of days covered with all four treatment classes	To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.	6 months
Secondary	(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	To describe the therapy optimization in different types of HFU and non-HFU centers.	6 months
Secondary	(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	To describe the therapy optimization in different types of HFU and non-HFU centers.	6 months
Secondary	Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool	To describe the utilization of HRQoL assessments in different types of HFU and non-HFU centers.	6 months
Secondary	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	To describe quality of treatment utilizing an all-or-none composite QI.	6 months
Secondary	Number of HF hospitalizations, stratified by bed type	Where a patient has multiple HF hospitalization stays, each hospitalization will be counted.; To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.	6 months
Secondary	Length of hospital stay	Length of hospital stay will be considered as the time from admission date until discharge for each HF hospitalization.; To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.	6 months
Secondary	Number of HF hospitalizations per patient	To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.	6 months
Secondary	Number of newly implanted devices	implanted devices: implantable cardioverter defibrillator (ICD), Cardiac resynchronization therapy (CRT), combination of ICD and CRT (CRT-D).; To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.	6 months
Secondary	Number of valve interventions	To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.	6 months
Secondary	Number of participants with medical history of selected comorbidities	To describe the HFrEF patient population with a recent decompensation	Baseline