This is an observational study in which data already collected from people treated with vericiguat are studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death. Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better. Vericiguat is available in Germany for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. However, there is limited information available about the use of vericiguat for the treatment of HFrEF under real-world conditions in routine medical care. The main purpose of this study is to collect information about how well vericiguat works in people with HFrEF who were newly treated with vericiguat. In addition, researchers will collect information about participants' basic characteristics, including their age, gender, other health conditions they might have, and the medicines they might be taking. The data will come from 2 German health databases including people who newly started vericiguat treatment between September 2021 and September 2023.
Study Type
OBSERVATIONAL
Enrollment
500
Vericiguat was given following routine clinical practice.
Bayer
Wuppertal, Germany
All-cause mortality rates after initiation of vericiguat
Number of patients who died between the "Vericiguat index date" and "cohort exit" according to their death date.
Time frame: Between September 2021 and September 2023
All-cause related hospitalization rates after initiation of vericiguat
Sum of all fully hospitalized cases of all patients between the "Vericiguat index date" and "cohort exit".
Time frame: Between September 2021 and September 2023
Heart failure related hospitalization rates after initiation of vericiguat
Sum of all fully hospitalized cases with a main or secondary inpatient diagnosis according to ICD-10 GM Code I50.x or I11.0 between the "Vericiguat index date" and "cohort exit".
Time frame: Between September 2021 and September 2023
Adherence of vericiguat drug use
Adherence will be assessed using the Medical Possession Ratio (MPR=days of supply/treatment duration).
Time frame: Between September 2021 and September 2023
Titration pattern of vericiguat drug use
Titration patterns will be assessed by investigating indicators such as the starting dose, the maximum dose reached as well as the time until up-titration.
Time frame: Between September 2021 and September 2023
Patient persistence of vericiguat drug use
Persistence will be calculated via the time until discontinuation of vericiguat.
Time frame: Between September 2021 and September 2023
Socio-demographic characteristics of patients initiating vericiguat at baseline
Sex and age groups.
Time frame: Between September 2021 and September 2023
Clinical characteristics of patients initiating vericiguat at baseline
Pre-defined comorbidities, pre-defined comedications, all-cause hospitalization, worsening hart failure event, etc.
Time frame: Between September 2021 and September 2023
Medication of interest in the 3 months before and after initiation of vericiguat
Time frame: Between September 2021 and September 2023
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