Observing the safety of vericiguat in Japanese patients with chronic heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather data on the safety of the drug vericiguat in Japanese individuals diagnosed with chronic heart failure. Participants will receive vericiguat as part of their standard treatment, and the study will monitor their health outcomes over time. The goal is to understand how vericiguat performs in a real-world setting, particularly among a broader population of Japanese patients, as previous data has been limited. This study is crucial for assessing the long-term safety of vericiguat in this specific demographic.

Why it matters

Who can join: the full rules

Inclusion Criteria:

vericiguat arm:

* Patients receiving standard treatment for chronic heart failure, and vericiguat will be treated in accordance with the package insert (no history of receiving vericiguat)
* Patients who gave written consent to this investigation

control arm:

* Patients receiving standard treatment for chronic heart failure according to the package insert of vericiguat as following (no history of receiving vericiguat)

  * Prior (within 6 months) heart failure hospitalization or prior (within 3 months) intravenous (IV) diuretics for heart failure not requiring hospitalization (This will be applied only for the first \~75% of patients meeting this criteria to be enrolled.) Note: No more than approximately 25% of patients without a qualifying history of prior heart failure hospitalization within 6 months or prior IV diuretics for heart failure not requiring hospitalization within 3 months can be enrolled in the study.
  * New York Heart Association (NYHA) Classification: Class II to Class IV
  * Left ventricular ejection fraction (LVEF): less than 45%
* Patients who gave written informed consent to this study

Exclusion Criteria:

vericiguat arm:

\- Patients who are participating in an interventional study

control arm:

* Patients who have started or are scheduled to start therapy with vericiguat for chronic heart failure
* Patients who are participating in an interventional study

Where it's running

• Japanese registries
  Multiple Locations, Many Locations, Japan Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.