Chronic Heart Failure, Chronic Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
HFrEF
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.
Interventions
DRUGvericiguat (BAY 1021189)
2.5 mg initiating dose
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rates of clinical outcomes in patients who initiate vericiguat | 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
| Measure | Time frame | Description |
|---|---|---|
| Pattern description of Heart Failure (HF) therapy before and after vericiguat initiation | Baseline and 1 year (after vericiguat initiation) | To describe the patterns of HF therapy before and after vericiguat initiation |
| characteristics of patients who initiate vericiguat: age | Baseline | Age in years: to document the age range of patients initiating vericiguat |
| characteristics of patients who initiate vericiguat: gender | Baseline | Gender: to document the gender distribution of patients initiating vericiguat |
| characteristics of patients who initiate vericiguat: BMI | Baseline | BMI (in kg/m2) at baseline - To describe the weight distribution of patients who initiate vericiguat |
| characteristics of patients who initiate vericiguat: recent Worsening Heart failure (WHF) | Baseline | Documentation of Recent WHF event: HF hospitalization within 6 months or outpatient IV diuretics within 3 months prior to index date. |
| characteristics of patients who initiate vericiguat, prior WHF | Baseline | Prior WHF: HF hospitalization or outpatient IV diuretics with no specified evaluation period |
| characteristics of patients who initiate vericiguat: Dialysis | Baseline | Document the number of patients on maintenance dialysis |
| characteristics of patients who initiate vericiguat: Time from recent WHF event | 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 |
| characteristics of patients who initiate vericiguat: Comorbidities | Baseline | Document Comorbidities at baseline |
| characteristics of patients who initiate vericiguat: setting | Baseline | Setting of vericiguat initiation: inpatient or outpatient setting - To describe the characteristics of patients who initiate vericiguat |
| 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 | 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 |
| characteristics of patients who initiate vericiguat: HF foundational therapy, prior index date | Baseline | HF foundational therapy within 90 days prior to index date |
| characteristics of patients who initiate vericiguat: Number of HF foundational therapy | Baseline | Number of HF foundational therapy within 90 days prior to index date |
| adherence of vericiguat therapy for 1 year after treatment initiation: medication possession ratio (MPR) | 1 year (after vericiguat initiation) | To describe the adherence of vericiguat therapy for 1 year after treatment initiation measured by medication possession ratio (MPR) |
| adherence of vericiguat therapy for 1 year after treatment initiation: proportion of days covered (PDC) | 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) |
| persistence of vericiguat therapy for 1 year after treatment initiation: Duration of continuous treatment over the first year after the index date | 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 |
| persistence of vericiguat therapy for 1 year after treatment initiation: percentage of patients with continuous treatment at Day 365 | 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 |
| Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Day-to-day patterns of vericiguat | 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 |
| 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 | 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 |
| Pattern description of dose titration of HF therapy before and after vericiguat initiation | Baseline and 1 year after vericiguat initiation | To describe the patterns of dose titration of HF therapy before and after vericiguat initiation |
| assess the change in laboratory and clinical parameters before and after vericiguat initiation | 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. |
| characteristics of patients who initiate vericiguat: cardiovascular procedure | Baseline | Document Cardiovascular procedures |
Countries
Japan
Outcome results
None listed