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

Bayer

Status: Completed

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Vericiguat (Verquvo, BAY1021189)

Study type: Observational

Funder types: Industry

Identifiers

NCT06486844

22829

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Patients who received vericiguat prescription

Description:

Patients who were new users of vericiguat between September 2021 and September 2023 from the InGef database and the WIG2 database.

Treatment:

Drug: Vericiguat (Verquvo, BAY1021189)