Real World Outcomes of Patients Treated with Vericiguat in German Routine Care (ROVER)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000221
• EU PAS number:
  EUPAS1000000221
• Study ID:
  1000000221
• Official title and acronym:
  Real World Outcomes of Patients Treated with Vericiguat in German Routine Care (ROVER)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  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 status:
  Ongoing

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Actual: 03/04/2024

Study start date

Planned: 05/07/2024

Actual: 05/07/2024

Date of final study report

Planned: 30/04/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

BAYER AG

Study protocol

Initial protocol

22829_Study Protocol_Redacted_V1.0_2024-07-04.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable