Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Wuppertal, 42096, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vericiguat (Verquvo, BAY1021189)

Drug

Vericiguat was given following routine clinical practice.

Primary outcomes

  1. All-cause mortality rates after initiation of vericiguat

    Time frame: Between September 2021 and September 2023

    Number of patients who died between the "Vericiguat index date" and "cohort exit" according to their death date.

  2. All-cause related hospitalization rates after initiation of vericiguat

    Time frame: Between September 2021 and September 2023

    Sum of all fully hospitalized cases of all patients between the "Vericiguat index date" and "cohort exit".

  3. Heart failure related hospitalization rates after initiation of vericiguat

    Time frame: Between September 2021 and September 2023

    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".

Secondary outcomes

  1. Adherence of vericiguat drug use

    Time frame: Between September 2021 and September 2023

    Adherence will be assessed using the Medical Possession Ratio (MPR=days of supply/treatment duration).

  2. Titration pattern of vericiguat drug use

    Time frame: Between September 2021 and September 2023

    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.

  3. Patient persistence of vericiguat drug use

    Time frame: Between September 2021 and September 2023

    Persistence will be calculated via the time until discontinuation of vericiguat.

  4. Socio-demographic characteristics of patients initiating vericiguat at baseline

    Time frame: Between September 2021 and September 2023

    Sex and age groups.

  5. Clinical characteristics of patients initiating vericiguat at baseline

    Time frame: Between September 2021 and September 2023

    Pre-defined comorbidities, pre-defined comedications, all-cause hospitalization, worsening hart failure event, etc.

  6. Medication of interest in the 3 months before and after initiation of vericiguat

    Time frame: Between September 2021 and September 2023

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: ROVER

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.