Skip to main content
OpenTrials
Completed

NCT Number: NCT06697353

An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan

This is an observational study in which data already collected from people with chronic heart failure is studied.

Chronic HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays or even death.

The study drug, vericiguat, is already approved for doctors to prescribe to people with chronic HFrEF in Japan.

Vericiguat increases the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels, allowing more blood to flow through. As a result, the heart is able to pump better.

The participants in this study are already receiving treatment with vericiguat (newly initiated) as part of their regular care from their doctors.

There is currently limited real-world data on the use of vericiguat in Japanese people. Therefore, more research is needed on larger groups of Japanese people for a longer period to understand the effects of use of vericiguat.

The main purpose of this study is to collect information about how well vericiguat is used in Japanese people with heart failure who initiate vericiguat treatment.

To do this, researchers will collect the following information for participants who newly initiated vericiguat:

occurrence of death due to heart and blood vessel related events

occurrence of death due to any reason

hospital stays due to heart failure

a combination of hospital stays due to heart failure or occurrence of death due to heart and blood-vessel related events

a combination of occurrence of death due to any reason or hospital stays due to heart failure

In addition, researchers will collect the following information:

participants' characteristics, including age, sex, height, weight, and medical history

how well did the participants follow their prescribed treatment with vericiguat over the year after starting it

how long did the participants continue to take vericiguat over the year after starting it

changes in the dose of vericiguat in the participants over the year after starting it

other treatment options participants have taken for the treatment of heart failure

changes in laboratory values and other test results before and after treatment with vericiguat

The data will come from the participants' hospital records provided by the Medical Data Vision Co., Ltd. They will cover the period from September 2016 to July 2024.

Researchers will track participants' data and will follow them for a maximum of one year after starting treatment with vericiguat, or until any of the following happens:

the participant dies

the participant cannot be tracked anymore

the end of the study

In this study, only available data from routine care are collected. No visits or tests are required as part of this study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Heart Failure Chronic Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who initiate vericiguat (identified by Anatomical Therapeutic Chemical [ATC] code C01DX22, generic name and receipt code [to be defined in the SAP]) between September 2021 and July 2024

  • Patients who have diagnosis code of HF (identified by World Health Organization [WHO] International Classification of Diseases, 10th revision [ICD-10] codes I50, I11.0) prior to index date
  • Patients aged 18 years or older at index date

Exclusion criteria

  • Patients with observability for less than 180 days prior to index date
  • Patients with a follow-up period of 0 days.

Treatment and study plan

vericiguat (BAY 1021189)

Drug

2.5 mg initiating dose

Other names: VERQUVO

Primary outcomes

  1. Incidence rates of clinical outcomes in patients who initiate vericiguat

    Time frame: Retrospective analysis from September 2016 to July 2024; Up to one year after vericiguat initiation

    To estimate the incidence rates of cardiovascular death, all-cause death, HF hospitalization, a composite of cardiovascular death or HF hospitalization, and a composite of all-cause death or HF hospitalization in patients who initiate vericiguat

Secondary outcomes

  1. characteristics of patients who initiate vericiguat: age

    Time frame: Baseline

    Age in years: to document the age range of patients initiating vericiguat

  2. characteristics of patients who initiate vericiguat: gender

    Time frame: Baseline

    Gender: to document the gender distribution of patients initiating vericiguat

  3. characteristics of patients who initiate vericiguat: BMI

    Time frame: Baseline

    BMI (in kg/m2) at baseline - To describe the weight distribution of patients who initiate vericiguat

  4. characteristics of patients who initiate vericiguat: recent Worsening Heart failure (WHF)

    Time frame: Baseline

    Documentation of Recent WHF event: HF hospitalization within 6 months or outpatient IV diuretics within 3 months prior to index date.

  5. characteristics of patients who initiate vericiguat, prior WHF

    Time frame: Baseline

    Prior WHF: HF hospitalization or outpatient IV diuretics with no specified evaluation period

  6. characteristics of patients who initiate vericiguat: Dialysis

    Time frame: Baseline

    Document the number of patients on maintenance dialysis

  7. characteristics of patients who initiate vericiguat: Time from recent WHF event

    Time frame: Baseline

    Treatment location after recent WHF event: HF hospitalization in the previous 3 months, HF hospitalization in the previous 3-6 months, and outpatient IV diuretics in the previous 3 months

  8. characteristics of patients who initiate vericiguat: Comorbidities

    Time frame: Baseline

    Document Comorbidities at baseline

  9. characteristics of patients who initiate vericiguat: setting

    Time frame: Baseline

    Setting of vericiguat initiation: inpatient or outpatient setting - To describe the characteristics of patients who initiate vericiguat

  10. characteristics of patients who initiate vericiguat: cardiovascular procedure

    Time frame: Baseline

    Document Cardiovascular procedures

  11. characteristics of patients who initiate vericiguat: HF foundational therapy, prior index date

    Time frame: Baseline

    HF foundational therapy within 90 days prior to index date

  12. characteristics of patients who initiate vericiguat: Number of HF foundational therapy

    Time frame: Baseline

    Number of HF foundational therapy within 90 days prior to index date

  13. adherence of vericiguat therapy for 1 year after treatment initiation: medication possession ratio (MPR)

    Time frame: 1 year (after vericiguat initiation)

    To describe the adherence of vericiguat therapy for 1 year after treatment initiation measured by medication possession ratio (MPR)

  14. adherence of vericiguat therapy for 1 year after treatment initiation: proportion of days covered (PDC)

    Time frame: 1 year (after vericiguat initiation)

    To describe the adherence of vericiguat therapy for 1 year after treatment initiation measured by proportion of days covered (PDC)

  15. persistence of vericiguat therapy for 1 year after treatment initiation: Duration of continuous treatment over the first year after the index date

    Time frame: 1 year (after vericiguat initiation)

    To describe the persistence of vericiguat therapy for 1 year after treatment initiation measured by the duration of continuous treatment

  16. persistence of vericiguat therapy for 1 year after treatment initiation: percentage of patients with continuous treatment at Day 365

    Time frame: 1 year (after vericiguat initiation)

    To describe the persistence of vericiguat therapy for 1 year after treatment initiation measured by the percentage of patients with continuous treatment at Day 365

  17. Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Day-to-day patterns of vericiguat

    Time frame: 1 year (after vericiguat initiation)

    To describe the patterns of dose titration of vericiguat over 1 year after treatment initiation measured by day-to-day patterns

  18. Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Time to up-titration of vericiguat from index date to Day 365

    Time frame: 1 year (after vericiguat initiation)

    To describe the patterns of dose titration of vericiguat over 1 year after treatment initiation measured by time to up-titration

  19. Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Time to up-titration to maximal daily dose of vericiguat from index date to Day 365

    Time frame: 1 year (after vericiguat initiation)

    To describe the patterns of dose titration of vericiguat over 1 year after treatment initiation measured by time to up-titration to maximal daily dose

  20. Pattern description of Heart Failure (HF) therapy before and after vericiguat initiation

    Time frame: Baseline and 1 year (after vericiguat initiation)

    To describe the patterns of HF therapy before and after vericiguat initiation

  21. Pattern description of dose titration of HF therapy before and after vericiguat initiation

    Time frame: Baseline and 1 year after vericiguat initiation

    To describe the patterns of dose titration of HF therapy before and after vericiguat initiation

  22. assess the change in laboratory and clinical parameters before and after vericiguat initiation

    Time frame: Baseline and 180 days after vericiguat initiation

    To assess the change in laboratory and clinical parameters before and after vericiguat initiation measured by SBP, LVEF, NYHA classification, NT-proBNP, BNP, eGFR, hemoglobin, number of HF hospitalization per patient, dose of diuretics, and number and percentage of patients with diuretic use.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

ROVER Japan/ Real-world Outcomes of Patients Treated With Vericiguat in Japanese Routine Care: a Retrospective Cohort Study Using a Hospital Administrative Database

Acronym: ROVER Japan

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Oct 8, 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.