Actively Recruiting

All Genders
NCT05666518

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

Led by Bayer · Updated on 2026-04-17

1400

Participants Needed

1

Research Sites

330 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients receiving standard treatment for chronic heart failure and vericiguat treatment according to the package insert with no prior vericiguat use (vericiguat arm)
  • Patients who gave written consent to participate in the vericiguat arm
  • Patients receiving standard treatment for chronic heart failure according to vericiguat package insert with no prior vericiguat use (control arm)
  • Patients with prior heart failure hospitalization within 6 months or intravenous diuretics for heart failure within 3 months (applies to about 75% of control arm patients)
  • Patients with New York Heart Association (NYHA) Class II to Class IV
  • Patients with left ventricular ejection fraction (LVEF) below 45%
  • Patients who gave written informed consent to participate (control arm)
Not Eligible

You will not qualify if you...

  • Patients participating in another interventional study (vericiguat arm)
  • Patients who have started or are scheduled to start vericiguat therapy for chronic heart failure (control arm)
  • Patients participating in another interventional study (control arm)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Japanese registries

Multiple Locations, Many Locations, Japan

Actively Recruiting

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Research Team

B

Bayer Clinical Trials Contact

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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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 | DecenTrialz