A Study to Learn More About the Safety of the Drug Vericiguat in Japanese People With Chronic Heart Failure Who Will be Receiving Vericiguat Under Real-world Conditions - Trial NCT05666518

Timeline & Enrollment

Primary Outcome

Severity of Adverse Events (AEs) for vericiguat arm,Seriousness of Adverse Events (AEs) for vericiguat arm,Outcome of Adverse Events (AEs) for vericiguat arm,Causality assessment of Adverse Events (AEs) for vericiguat arm,Incidence of Cardiovascular (CV) death for vericiguat arm and control arm

Summary

This is an observational study in which data from Japanese people with chronic heart failure
 who will be receiving vericiguat is studied.
 
 Chronic heart failure (HF) is a long-term condition where the heart does not pump blood as
 well as it should. Heart failure can lead to other serious medical conditions, and it can
 lead to hospitalization or death.
 
 The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate
 cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation. Vericiguat is
 already available and approved for doctors to prescribe to people who have heart failure. A
 limited number of patients have been treated with vericiguat. Therefore information about its
 safety in a broader population and especially among Japanese people as well as for prolonged
 periods of treatment is still missing.
 
 In this study, the researchers want to learn more about how safe vericiguat is if used in
 Japanese people with long term HF. To see how safe vericiguat is, the researchers will
 collect the medical problems the participants have during the treatment with vericiguat under
 real-word conditions. They will particularly focus on the following:
 
 - high blood pressure
 
 - any medical problems due to combination of the study treatment vericiguat with nitrates
 and nitric oxide (NO) donors or with PDE5 inhibitors
 
 - medical problems in participants with liver problems or with reduced kidney function
 
 - medical problems in participants with low blood pressure below 100 mmHg or with
 symptoms due to low blood pressure
 
 - any medical problems after prolonged periods of treatment with vericiguat. These medical
 problems are also known as adverse events (AEs) which may or may not be related to the
 study treatment.
 
 In addition, this study will gather information about how long vericiguat treatment can
 prevent death caused by cardiovascular problems such as heart attack and stroke compared to
 standard of care. Cardiovascular death (safety specification) will be assessed in a
 comparative manner with the control arm as the primary objective
 
 The participants will receive their treatments as prescribed by their doctors according to
 the approved product information. The data for this study will be collected using an
 electronic case report form (eCRF) and medical records. The following data from the study
 participants will be documented during visits that take place in routine practice:
 
 - underlying and concomitant diseases,
 
 - prior medication,
 
 - treatment duration,
 
 - laboratory parameters,
 
 - vital signs,
 
 - results of cardiac exams (e.g. cardiac ultrasound),
 
 - heart failure related hospitalization events,
 
 - adverse events. The data collection will start from the beginning of vericiguat/standard
 of care treatment and will cover a time period of 2 years unless no further information
 can be expected from the participant at a given point in time, or death.
 
 The total study duration will be six years, including data analysis and cleaning.

ICD-10 Classifications