pause_circle_filledNot Yet Recruiting

Chronic heart failure, Chronic heart failure with reduced ejection fraction

Bayer Identifier:

22849

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
An observational study to learn more about the real-world outcomes in patients with heart failure who initiate treatment with vericiguat in Japan

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

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

Trial summary

Enrollment Goal
7000
Trial Dates
November 2024 - June 2025
Phase
N/A
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Many LocationsMany Locations, Japan

Primary Outcome

  • Incidence rates of clinical outcomes in patients who initiate vericiguat
    The incidence rates of the 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 will be assessed for patients newly prescribed with vericiguat (primary objective).
    date_rangeTime Frame:
    throughout the study

Secondary Outcome

  • characteristics of patients who initiate vericiguat
    • Age • Sex • BMI at baseline • Dialysis: patients on maintenance dialysis, identified by procedure code • HF hospitalization within 180 days or outpatient intravenous (IV) diuretic use within the 90 days from index date and at index date • Time from 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 and at index date Prior WHF: hospitalization for HF, outpatient treatment intensification, emergency department visits not leading to hospitalization, with no specified evaluation period • Setting of vericiguat initiation: inpatient or outpatient setting • Comorbidities at baseline • Cardiovascular procedure • HF foundational therapy before the index date at baseline (within the 90 days prior to index date) • Number of HF foundational therapy 90 days prior to the index date
    date_rangeTime Frame:
    from baseline
  • adherence of vericiguat therapy for 1 year after treatment initiation
    Adherence to vericiguat treatment will be investigated from index date to the end of follow-up by measuring: • Medication possession ratio (MPR): Defined as the number of days of vericiguat supply divided by the number of days of treatment duration, from index date to 1 year of follow-up. Adherence to vericiguat treatment will be considered if the medication possession ration of ≥80%. - Proportion of days covered (PDC): Measure of adherence, defined as the number of days a patient has a medication supply available divided by the total number of days in the time period, from index date to 1 year of follow-up.
    date_rangeTime Frame:
    throughout the study
  • persistence of vericiguat therapy for 1 year after treatment initiation
    Persistence to vericiguat treatment will be investigated from index date to the end of follow-up by measuring: • Duration of continuous treatment over the first year after the index date • Percentage of patients with continuous treatment at Day 365 Duration of continuous treatment over the first year after the index date will be operationalized as time until discontinuation. A continuous treatment will be assumed, if a subsequent prescription occurred either within the days of supply of the previous prescription or during a grace period of 90 days thereafter. The definition of discontinuation of vericiguat = date of discontinuation will be the end date of the last continuous prescription.
    date_rangeTime Frame:
    throughout the study
  • Pattern description of dose titration of vericiguat over 1 year after treatment initiation
    The following variables will be considered within different time periods: • Day-to-day patterns of vericiguat dose titration over 1 year after the index date - Time to up-titration and time to up-titration to maximal daily dose of vericiguat from index date to Day 365
    date_rangeTime Frame:
    throughout the study
  • Pattern description of HF therapy before and after vericiguat initiation
    The following variables will be considered within different time periods: - Use of HF therapy (i.e., ACEi, ARBs, ARNI, ARB/ACEi and ARB/ACEi/ARNI, BB, MRA, SGLT2i) at Day -90, 0, 90, 180 and 365
    date_rangeTime Frame:
    throughout the study
  • Pattern description of dose titration of HF therapy before and after vericiguat initiation
    The following variables will be considered within different time periods: • Dose titration (high dose, medium dose, and low dose) of HF therapy (i.e., ACEi, ARBs, ARNI, MRA and BB) starting from Day -90 to Day 365, and from Day -90 to Day 365 A similar graph will be displayed, with the prescribed or dispensed dose of SGLT2i (SGLT2i do not require dose titrations) from Day -90 to Day 365.
    date_rangeTime Frame:
    throughout the study
  • assess the change in laboratory and clinical parameters before and after vericiguat initiation
    The results of the laboratory and other outcomes will be considered at pre- (i.e., Day -90 to Day -1) and post-vericiguat (i.e., post-initiation period 1: Day 1 to Day 90, Post-initiation period 2: Day 91 to Day 180) initiation. If multiple records of laboratory and clinical parameters exist in a patient, the result reported closest to the index date (pre-initiation period) and the result last reported during the time window (post-initiation period 1 and post-initiation period 2) will be considered.
    date_rangeTime Frame:
    Day -90 to Day 180

Trial design

ROVER Japan/ real-world outcomes of patients treated with vericiguat in Japanese routine care: a retrospective cohort study using a hospital administrative database
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Health Services Research
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information