Clinical trial NCT06697353: An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan
Official title: ROVER Japan/ Real-world Outcomes of Patients Treated With Vericiguat in Japanese Routine Care: a Retrospective Cohort Study Using a Hospital Administrative Database
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Heart Failure
Chronic Heart Failure With Reduced Ejection Fraction
Keywords: HFrEF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is composed of adult patients with HF diagnosis code between March 2021 and July 2024, initiating vericiguat between September 2021 and July 2024, with HF diagnosis prior to index date, and with at least 180 days of observation prior to index date.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence rates of clinical outcomes in patients who initiate vericiguat
timeFrame: Retrospective analysis from September 2016 to July 2024; Up to one year after vericiguat initiation
Secondary outcomes:
measure: characteristics of patients who initiate vericiguat: age
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: gender
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: BMI
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: recent Worsening Heart failure (WHF)
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat, prior WHF
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: Dialysis
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: Time from recent WHF event
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: Comorbidities
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: setting
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: cardiovascular procedure
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: HF foundational therapy, prior index date
timeFrame: Baseline
measure: characteristics of patients who initiate vericiguat: Number of HF foundational therapy
timeFrame: Baseline
measure: adherence of vericiguat therapy for 1 year after treatment initiation: medication possession ratio (MPR)
timeFrame: 1 year (after vericiguat initiation)
measure: adherence of vericiguat therapy for 1 year after treatment initiation: proportion of days covered (PDC)
timeFrame: 1 year (after vericiguat initiation)
measure: persistence of vericiguat therapy for 1 year after treatment initiation: Duration of continuous treatment over the first year after the index date
timeFrame: 1 year (after vericiguat initiation)
measure: persistence of vericiguat therapy for 1 year after treatment initiation: percentage of patients with continuous treatment at Day 365
timeFrame: 1 year (after vericiguat initiation)
measure: Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Day-to-day patterns of vericiguat
timeFrame: 1 year (after vericiguat initiation)
measure: 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
timeFrame: 1 year (after vericiguat initiation)
measure: 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
timeFrame: 1 year (after vericiguat initiation)
measure: Pattern description of Heart Failure (HF) therapy before and after vericiguat initiation
timeFrame: Baseline and 1 year (after vericiguat initiation)
measure: Pattern description of dose titration of HF therapy before and after vericiguat initiation
timeFrame: Baseline and 1 year after vericiguat initiation
measure: assess the change in laboratory and clinical parameters before and after vericiguat initiation
timeFrame: Baseline and 180 days after vericiguat initiation
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
References: