Clinical trial NCT06486844: An Observational Study Called ROVER to Learn More About How Well Vericiguat Works in People Who Were Newly Treated With Vericiguat in Routine Medical Care in Germany
Official title: Real World Outcomes of Patients Treated With Vericiguat in German Routine Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Keywords: HFrEF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with their first vericiguat prescription since market authorization in September 2021 who are aged 18 years or older will be included in the study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with an initial prescription of Vericiguat (index date) according to ATC Code C01DX22.
* At least 18 years or older on the initial prescription of Vericiguat.

Exclusion Criteria:

* No exclusion criteria for any population will be applied.

Primary outcomes:
measure: All-cause mortality rates after initiation of vericiguat
timeFrame: Between September 2021 and September 2023
measure: All-cause related hospitalization rates after initiation of vericiguat
timeFrame: Between September 2021 and September 2023
measure: Heart failure related hospitalization rates after initiation of vericiguat
timeFrame: Between September 2021 and September 2023
Secondary outcomes:
measure: Adherence of vericiguat drug use
timeFrame: Between September 2021 and September 2023
measure: Titration pattern of vericiguat drug use
timeFrame: Between September 2021 and September 2023
measure: Patient persistence of vericiguat drug use
timeFrame: Between September 2021 and September 2023
measure: Socio-demographic characteristics of patients initiating vericiguat at baseline
timeFrame: Between September 2021 and September 2023
measure: Clinical characteristics of patients initiating vericiguat at baseline
timeFrame: Between September 2021 and September 2023
measure: Medication of interest in the 3 months before and after initiation of vericiguat
timeFrame: Between September 2021 and September 2023
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: Bayer
Study officials:
References: