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 (ROVER)

Real World Outcomes of Patients Treated With Vericiguat in German Routine Care

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 Overview

• Status: Completed
• Conditions: Chronic Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Drug: Vericiguat (Verquvo, BAY1021189)

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Germany
  • Wuppertal, Germany, 42096
    • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Vericiguat was given following routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence of vericiguat drug use	Adherence will be assessed using the Medical Possession Ratio (MPR=days of supply/treatment duration).	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.	Between September 2021 and September 2023
Patient persistence of vericiguat drug use	Persistence will be calculated via the time until discontinuation of vericiguat.	Between September 2021 and September 2023
Socio-demographic characteristics of patients initiating vericiguat at baseline	Sex and age groups.	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.	Between September 2021 and September 2023
Medication of interest in the 3 months before and after initiation of vericiguat		Between September 2021 and September 2023

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2024
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: HFrEF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; vericiguat
• Other Study ID Numbers: 22829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No