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

NCT06486844 | Completed

• 1 other identifier: 22829
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Keywords

HFrEF

Outcome Measures

Primary Outcomes (3)

• 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.

  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".

  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".

  Between September 2021 and September 2023

Secondary Outcomes (6)

• Adherence of vericiguat drug use

  Between September 2021 and September 2023

• Titration pattern of vericiguat drug use

  Between September 2021 and September 2023

• Patient persistence of vericiguat drug use

  Between September 2021 and September 2023

• Socio-demographic characteristics of patients initiating vericiguat at baseline

  Between September 2021 and September 2023

• Clinical characteristics of patients initiating vericiguat at baseline

  Between September 2021 and September 2023

Study Arms (1)

Patients who received vericiguat prescription

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

Drug: Vericiguat (Verquvo, BAY1021189)

Interventions

Vericiguat (Verquvo, BAY1021189) DRUG

Vericiguat was given following routine clinical practice.

Patients who received vericiguat prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Wuppertal, 42096, Germany

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

MeSH Terms

Interventions

vericiguat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 5, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)