Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care
- Conditions
- Heart Failure
- Interventions
- Other: Heart Failure medications
- Registration Number
- NCT06004453
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 899
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort B Heart Failure medications Non-HFU Hospitals Cohort E Heart Failure medications General practitioners Cohort D Heart Failure medications Non-HFU Residential Cardiologists Cohort A Heart Failure medications Supra-regional HFU Centers and HFU Focus Hospitals Cohort C Heart Failure medications HFU Residential Cardiologists
- Primary Outcome Measures
Name Time Method Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint 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 Outcome Measures
Name Time Method (A) Proportion of patients with HF who have a documentation of their HF clinical type 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.(D) Proportion of patients who have their blood tests documented 3 months To describe the patient assessment in different types of HFU and non-HFU centers.
(F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge 4 weeks To describe the patient assessment in different types of HFU and non-HFU centers.
(B) Proportion of patients with a documentation of their electrocardiogram findings 6 months To describe the patient assessment in different types of HFU and non-HFU centers.
(C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation) 3 months To describe the patient assessment in different types of HFU and non-HFU centers.
(E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program 6 months To describe the patient assessment in different types of HFU and non-HFU centers.
(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 6 months To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment 6 months To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Length of hospital stay 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.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 6 months To describe quality of treatment utilizing an all-or-none composite QI.
Number of HF hospitalizations, stratified by bed type 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.Number of valve interventions 6 months To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Proportion of sites with a dedicated multidisciplinary team to manage patients with HF Baseline To describe the structural framework of the participating centers.
Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care. Baseline To describe the structural framework of the participating centers.
(I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications 6 months To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
(J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications 6 months To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Number of HF hospitalizations per patient 6 months To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
(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 6 months To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention 6 months To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Percentage of days covered with all four treatment classes 6 months To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
(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 6 months To describe the therapy optimization in different types of HFU and non-HFU centers.
Number of participants with medical history of selected comorbidities Baseline To describe the HFrEF patient population with a recent decompensation
Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together 6 months To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
(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 6 months To describe the therapy optimization in different types of HFU and non-HFU centers.
Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool 6 months To describe the utilization of HRQoL assessments in different types of HFU and non-HFU centers.
Number of newly implanted devices 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.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Wuerzburg, Germany