An observational study in Heart Failure, sponsored by Novartis Pharmaceuticals. Completed at 94 sites in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Novartis Pharmaceuticals · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 899 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Heart failure with reduced ejection fraction patients with a recent decompensation event
Exclusion Criteria:
Supra-regional HFU Centers and HFU Focus Hospitals
Other: Heart Failure medications
Non-HFU Hospitals
Other: Heart Failure medications
HFU Residential Cardiologists
Other: Heart Failure medications
Non-HFU Residential Cardiologists
Other: Heart Failure medications
General practitioners
Other: Heart Failure medications
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.
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.
Time frame: 6 months
Proportion of sites with a dedicated multidisciplinary team to manage patients with HF
To describe the structural framework of the participating centers.
Time frame: Baseline
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.
Time frame: Baseline
(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.
Time frame: Baseline
(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.
Time frame: 6 months
(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.
Time frame: 3 months
(D) Proportion of patients who have their blood tests documented
To describe the patient assessment in different types of HFU and non-HFU centers.
Time frame: 3 months
(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.
Time frame: 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
To describe the patient assessment in different types of HFU and non-HFU centers.
Time frame: 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
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Time frame: 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
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Time frame: 6 months
(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.
Time frame: 6 months
(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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 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
To describe the therapy optimization in different types of HFU and non-HFU centers.
Time frame: 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
To describe the therapy optimization in different types of HFU and non-HFU centers.
Time frame: 6 months
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.
Time frame: 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
To describe quality of treatment utilizing an all-or-none composite QI.
Time frame: 6 months
Number of HF hospitalizations, stratified by bed type
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.
Time frame: 6 months
Length of hospital stay
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.
Time frame: 6 months
Number of HF hospitalizations per patient
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Time frame: 6 months
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.
Time frame: 6 months
Number of valve interventions
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Time frame: 6 months
Number of participants with medical history of selected comorbidities
To describe the HFrEF patient population with a recent decompensation
Time frame: Baseline
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals