Observing the safety of vericiguat in Japanese patients with chronic heart failure
Vericiguat Drug Use Two-arm Investigation in Chronic Heart Failure
This study is testing how safe the drug vericiguat is for Japanese patients with chronic heart failure as they use it in their regular treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations, Many Locations) |
| Trial ID | NCT05666518 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are Japanese individuals with chronic heart failure who are receiving standard treatment and have not previously been treated with vericiguat.
Not a fit: Patients who do not have chronic heart failure or those who have previously received vericiguat may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of vericiguat, potentially leading to improved treatment options for patients with chronic heart failure.
How similar studies have performed: While vericiguat has been studied in other populations, this specific observational approach focusing on Japanese patients is novel and aims to fill existing data gaps.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Multiple Locations, Many Locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.