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Completed

NCT Number: NCT06004453

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Heidelberg, Baden-Wurttemberg, Germany

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About this study

This study aimed 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 was imposed on participants to avoid interference with routine clinical care. HFrEF patients were treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data was collected as part of the study from patient files.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Decompensation event up to three months prior to inclusion

Exclusion criteria

  • 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

Treatment and study plan

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.

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

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. (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.

  4. (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.

  5. (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.

  6. (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.

  7. (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.

  8. (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.

  9. (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.

  10. (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.

  11. (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.

  12. (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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. (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.

  18. (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.

  19. 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.

  20. 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.

  21. Number of HF hospitalizations, stratified by bed type

    Time frame: 6 months

    Where a patient had multiple HF hospitalization stays, each hospitalization was counted.

    To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.

  22. Length of hospital stay

    Time frame: 6 months

    Length of hospital stay was 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.

  23. 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.

  24. 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.

  25. Number of valve interventions

    Time frame: 6 months

    To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.

  26. Number of participants with medical history of selected comorbidities

    Time frame: Baseline

    To describe the HFrEF patient population with a recent decompensation

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: CONNECT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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