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

Bayer4,936 enrolled

Overview

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence rates of clinical outcomes in patients who initiate vericiguat

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

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

Secondary Outcomes

characteristics of patients who initiate vericiguat: age

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

Time frame: Baseline

characteristics of patients who initiate vericiguat: gender

Gender: to document the gender distribution of patients initiating vericiguat

Time frame: Baseline

characteristics of patients who initiate vericiguat: BMI

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

Time frame: Baseline

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

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

Time frame: Baseline

characteristics of patients who initiate vericiguat, prior WHF

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

Time frame: Baseline

characteristics of patients who initiate vericiguat: Dialysis

Document the number of patients on maintenance dialysis

Time frame: Baseline

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

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

Time frame: Baseline

characteristics of patients who initiate vericiguat: Comorbidities

Document Comorbidities at baseline

Time frame: Baseline

characteristics of patients who initiate vericiguat: setting

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

Time frame: Baseline

characteristics of patients who initiate vericiguat: cardiovascular procedure

Document Cardiovascular procedures

Time frame: Baseline

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

HF foundational therapy within 90 days prior to index date

Time frame: Baseline

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

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

Time frame: Baseline

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

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