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

April 25, 2024 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Germany
      • Aichach, Germany, 86551
        • Recruiting
        • Novartis Investigative Site
      • Amberg, Germany, 92224
        • Recruiting
        • Novartis Investigative Site
      • Augsburg, Germany, 86163
        • Recruiting
        • Novartis Investigative Site
      • Bad Homburg, Germany, 61348
        • Recruiting
        • Novartis Investigative Site
      • Bad Neustadt, Germany, 97616
        • Recruiting
        • Novartis Investigative Site
      • Bad Vilbel, Germany, 61118
        • Recruiting
        • Novartis Investigative Site
      • Bechhofen, Germany, 66894
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, D 10559
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 13053
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 10365
        • Recruiting
        • Novartis Investigative Site
      • Bexbach, Germany, 66450
        • Recruiting
        • Novartis Investigative Site
      • Biedenkopf, Germany, 35216
        • Recruiting
        • Novartis Investigative Site
      • Biederitz OT Heyrothsberge, Germany, 39175
        • Recruiting
        • Novartis Investigative Site
      • Bitterfeld, Germany, 06749
        • Recruiting
        • Novartis Investigative Site
      • Breuberg, Germany, 64747
        • Recruiting
        • Novartis Investigative Site
      • Brilon, Germany, 59929
        • Recruiting
        • Novartis Investigative Site
      • Bruchsal, Germany, 76646
        • Recruiting
        • Novartis Investigative Site
      • Brueel, Germany, 19412
        • Recruiting
        • Novartis Investigative Site
      • Chemnitz, Germany, 09116
        • Recruiting
        • Novartis Investigative Site
      • Coburg, Germany, 96450
        • Recruiting
        • Novartis Investigative Site
      • Dessau-Rosslau, Germany, 06847
        • Recruiting
        • Novartis Investigative Site
      • Dinkelsbuhl, Germany, 91550
        • Recruiting
        • Novartis Investigative Site
      • Dresden, Germany, 01277
        • Recruiting
        • Novartis Investigative Site
      • Dresden, Germany, 01397
        • Recruiting
        • Novartis Investigative Site
      • Duesseldorf, Germany, 40225
        • Recruiting
        • Novartis Investigative Site
      • Duessledorf, Germany, 40217
        • Recruiting
        • Novartis Investigative Site
      • Duisburg, Germany, 47051
        • Recruiting
        • Novartis Investigative Site
      • Ehingen, Germany, 89584
        • Recruiting
        • Novartis Investigative Site
      • Ehringshausen, Germany, 35630
        • Recruiting
        • Novartis Investigative Site
      • Erfurt, Germany, 99097
        • Recruiting
        • Novartis Investigative Site
      • Farchant, Germany, 82490
        • Recruiting
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Recruiting
        • Novartis Investigative Site
      • Frankfurt, Germany, 60316
        • Recruiting
        • Novartis Investigative Site
      • Freiberg, Germany, 09559
        • Recruiting
        • Novartis Investigative Site
      • Fulda, Germany, 36037
        • Recruiting
        • Novartis Investigative Site
      • Gera, Germany, D 07551
        • Recruiting
        • Novartis Investigative Site
      • Giengen, Germany, 89537
        • Recruiting
        • Novartis Investigative Site
      • Goeppingen, Germany, 73033
        • Recruiting
        • Novartis Investigative Site
      • Hagen, Germany, 58135
        • Recruiting
        • Novartis Investigative Site
      • Halle (Saale), Germany, 06120
        • Recruiting
        • Novartis Investigative Site
      • Halle S, Germany, 06120
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20095
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 22087
        • Recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69115
        • Recruiting
        • Novartis Investigative Site
      • Homburg, Germany, 66421
        • Recruiting
        • Novartis Investigative Site
      • Hoppegarten, Germany, 15366
        • Recruiting
        • Novartis Investigative Site
      • Hoyerswerda, Germany, 02977
        • Recruiting
        • Novartis Investigative Site
      • Ingelheim, Germany, 55218
        • Recruiting
        • Novartis Investigative Site
      • Jerichow, Germany, 39319
        • Recruiting
        • Novartis Investigative Site
      • Kaiserslautern, Germany, 67657
        • Recruiting
        • Novartis Investigative Site
      • Kassel, Germany, 34121
        • Recruiting
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Recruiting
        • Novartis Investigative Site
      • Kiel, Germany, 24106
        • Recruiting
        • Novartis Investigative Site
      • Kitzingen, Germany, 97318
        • Recruiting
        • Novartis Investigative Site
      • Kleve, Germany, 47533
        • Recruiting
        • Novartis Investigative Site
      • Lahnau, Germany, 35633
        • Recruiting
        • Novartis Investigative Site
      • Leer, Germany, 26789
        • Recruiting
        • Novartis Investigative Site
      • Leipzig, Germany, 04209
        • Recruiting
        • Novartis Investigative Site
      • Leipzig, Germany, 04129
        • Recruiting
        • Novartis Investigative Site
      • Limbach-Oberfrohna, Germany, 09212
        • Recruiting
        • Novartis Investigative Site
      • Loehne, Germany, 32584
        • Recruiting
        • Novartis Investigative Site
      • Ludwigshafen, Germany, 67067
        • Recruiting
        • Novartis Investigative Site
      • Lutherstadt Wittenberg, Germany, 06886
        • Recruiting
        • Novartis Investigative Site
      • Lübeck, Germany, 23569
        • Recruiting
        • Novartis Investigative Site
      • Markkleeberg, Germany, 04416
        • Recruiting
        • Novartis Investigative Site
      • Moers, Germany, 47441
        • Recruiting
        • Novartis Investigative Site
      • Muellheim, Germany, 79379
        • Recruiting
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Recruiting
        • Novartis Investigative Site
      • Nuernberg, Germany, 90461
        • Recruiting
        • Novartis Investigative Site
      • Oberhausen, Germany, 46149
        • Recruiting
        • Novartis Investigative Site
      • Osnabrueck, Germany, 49074
        • Completed
        • Novartis Investigative Site
      • Papenburg, Germany, 26871
        • Recruiting
        • Novartis Investigative Site
      • Peine, Germany, 31224
        • Recruiting
        • Novartis Investigative Site
      • Penzberg, Germany, 82377
        • Recruiting
        • Novartis Investigative Site
      • Potsdam, Germany, 14471
        • Recruiting
        • Novartis Investigative Site
      • Radebeul, Germany, 01445
        • Recruiting
        • Novartis Investigative Site
      • Rastatt, Germany, 76437
        • Recruiting
        • Novartis Investigative Site
      • Remscheid, Germany, 42859
        • Recruiting
        • Novartis Investigative Site
      • Rostock, Germany, 18107
        • Recruiting
        • Novartis Investigative Site
      • Rotenburg an der Fulda, Germany, 36199
        • Recruiting
        • Novartis Investigative Site
      • Rudersberg, Germany, 73635
        • Recruiting
        • Novartis Investigative Site
      • Saarlouis, Germany, 66740
        • Recruiting
        • Novartis Investigative Site
      • Schoenebeck, Germany, 39218
        • Recruiting
        • Novartis Investigative Site
      • Schwandorf, Germany, 92421
        • Recruiting
        • Novartis Investigative Site
      • Siegen, Germany, 57072
        • Recruiting
        • Novartis Investigative Site
      • Speyer, Germany, 67346
        • Recruiting
        • Novartis Investigative Site
      • Stadtbergen, Germany, 86391
        • Recruiting
        • Novartis Investigative Site
      • Stadtlohn, Germany, 48703
        • Recruiting
        • Novartis Investigative Site
      • Stahnsdorf, Germany, 14532
        • Recruiting
        • Novartis Investigative Site
      • Stuttgart, Germany, 70376
        • Recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89077
        • Recruiting
        • Novartis Investigative Site
      • Urbach, Germany, 99765
        • Recruiting
        • Novartis Investigative Site
      • Wedemark, Germany, 30900
        • Recruiting
        • Novartis Investigative Site
      • Wenden, Germany, 57482
        • Recruiting
        • Novartis Investigative Site
      • Wermsdorf, Germany, 04779
        • Recruiting
        • Novartis Investigative Site
      • Wiesbaden, Germany, D-65199
        • Recruiting
        • Novartis Investigative Site
      • Winsen, Germany, 21423
        • Recruiting
        • Novartis Investigative Site
      • Wismar, Germany, 23966
        • Recruiting
        • Novartis Investigative Site
      • Wuerzburg, Germany, 97080
        • Recruiting
        • Novartis Investigative Site
    • Lower Saxony
      • Winsen, Lower Saxony, Germany, 21423
        • Recruiting
        • Novartis Investigative Site
    • Niedersachsen
      • Braunschweig, Niedersachsen, Germany, 38126
        • Recruiting
        • Novartis Investigative Site
    • Ossweil
      • Ludwigsburg, Ossweil, Germany, 71840
        • Recruiting
        • Novartis Investigative Site
    • Pfalz
      • Frankenthal, Pfalz, Germany, 67227
        • Recruiting
        • Novartis Investigative Site
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, Germany, 67655
        • Recruiting
        • Novartis Investigative Site
    • Saarland
      • Kleinblittersdorf, Saarland, Germany, 66271
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Chemnitz, Saxony, Germany, 09113
        • Recruiting
        • Novartis Investigative Site
      • Pirna, Saxony, Germany, 01796
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A
Supra-regional HFU Centers and HFU Focus Hospitals
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.
Cohort B
Non-HFU Hospitals
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.
Cohort C
HFU Residential Cardiologists
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.
Cohort D
Non-HFU Residential Cardiologists
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.
Cohort E
General practitioners
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of sites with a dedicated multidisciplinary team to manage patients with HF
Time Frame: Baseline
To describe the structural framework of the participating centers.
Baseline
Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.
Time Frame: Baseline
To describe the structural framework of the participating centers.
Baseline
(A) Proportion of patients with HF who have a documentation of their HF clinical type
Time Frame: Baseline

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
(B) Proportion of patients with a documentation of their electrocardiogram findings
Time Frame: 6 months
To describe the patient assessment in different types of HFU and non-HFU centers.
6 months
(C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)
Time Frame: 3 months
To describe the patient assessment in different types of HFU and non-HFU centers.
3 months
(D) Proportion of patients who have their blood tests documented
Time Frame: 3 months
To describe the patient assessment in different types of HFU and non-HFU centers.
3 months
(E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program
Time Frame: 6 months
To describe the patient assessment in different types of HFU and non-HFU centers.
6 months
(F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge
Time Frame: 4 weeks
To describe the patient assessment in different types of HFU and non-HFU centers.
4 weeks
(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
Time Frame: 6 months
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
6 months
(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
Time Frame: 6 months
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
6 months
(I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications
Time Frame: 6 months
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
6 months
(J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications
Time Frame: 6 months
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
6 months
Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment
Time Frame: 6 months
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
6 months
Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention
Time Frame: 6 months
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
6 months
Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together
Time Frame: 6 months
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
6 months
Percentage of days covered with all four treatment classes
Time Frame: 6 months
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
6 months
(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
Time Frame: 6 months
To describe the therapy optimization in different types of HFU and non-HFU centers.
6 months
(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
Time Frame: 6 months
To describe the therapy optimization in different types of HFU and non-HFU centers.
6 months
Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool
Time Frame: 6 months
To describe the utilization of HRQoL assessments in different types of HFU and non-HFU centers.
6 months
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
Time Frame: 6 months
To describe quality of treatment utilizing an all-or-none composite QI.
6 months
Number of HF hospitalizations, stratified by bed type
Time Frame: 6 months

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
Length of hospital stay
Time Frame: 6 months

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
Number of HF hospitalizations per patient
Time Frame: 6 months
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
6 months
Number of newly implanted devices
Time Frame: 6 months

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
Number of valve interventions
Time Frame: 6 months
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
6 months
Number of participants with medical history of selected comorbidities
Time Frame: Baseline
To describe the HFrEF patient population with a recent decompensation
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCZ696BDE06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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