An Observational Study, Called VERI-China, to Learn More About How Well Vericiguat Works and How Safe it is in Real-world Setting in People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in China

Launched by BAYER · Feb 6, 2023

Keywords

ClinConnect Summary

The VERI-China study is looking to understand how well the medication vericiguat works and how safe it is for people in China who have chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a condition where the heart struggles to pump blood effectively, which can lead to symptoms like shortness of breath and fatigue. This study will collect information from patients currently taking vericiguat and compare it to data from those receiving standard treatment for heart failure. The goal is to see if vericiguat can help prevent serious problems like hospital stays or death related to heart issues.

To participate in this study, you need to be at least 18 years old and have experienced worsening heart failure recently. If you have never taken vericiguat before and your doctor decides it’s the right treatment for you, you may be eligible for the vericiguat group. Participants will take vericiguat as prescribed and will have follow-up visits every three months for up to a year, during which various health information will be collected. This study is important because it aims to gather real-world data about the effectiveness and safety of vericiguat in everyday life, helping to inform better treatment options for patients with HFrEF.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • vericiguat arm
• • Female and male patients ≥ 18 years of age who are naïve to vericiguat treatment
• • Patients with HFrEF after a recent decompensation episode (within 6 months of heart failure hospitalization or within 3 months of intravenous (IV) diuretics for heart failure not requiring hospitalization)
• • Decision to initiate treatment with vericiguat as per the local approved label
• • Signed informed consent
• • control arm
• • Aged 18 or over at baseline
• • Only patients receiving SoC for chronic heart failure (no history of receiving vericiguat prior to the index date)
• • Patients with HFrEF after a recent decompensation episode (within 6 months of heart failure hospitalization or within 3 months of intravenous (IV) diuretics for heart failure not requiring hospitalization)
• Exclusion Criteria:
• • vericiguat arm
• • Participation in other investigational program with interventions outside of routine clinical practice
• • Contra-indications according to the local marketing authorization label
• • control arm
• • Patients who have started therapy with vericiguat for chronic heart failure at baseline
• • Contra-indications according to the vericiguat local marketing authorization label
• • Patients participating in an interventional study