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Chronic heart failure with reduced ejection fraction

Bayer Identifier:

22829

ClinicalTrials.gov Identifier:

NCT06486844

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - No exclusion criteria for any population will be applied.

Trial summary

Enrollment Goal
500
Trial Dates
July 2024 - March 2025
Phase
Phase 4
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
BayerWuppertal, 42096, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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”.
    date_rangeTime Frame:
    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”.
    date_rangeTime Frame:
    Between September 2021 and September 2023

Secondary Outcome

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

Trial design

Real World Outcomes of Patients Treated with Vericiguat in German Routine Care
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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