Observational study on the effectiveness and safety of vericiguat in patients with chronic heart failure in China
A Multi-center, Two-arm, Open-label, Externally Controlled, Post-marketing Study of the Effectiveness and Safety of Vericiguat in HFrEF Patients in China
This study looks at how well the heart medication vericiguat works and how safe it is for adults with chronic heart failure in China compared to standard treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations, Many Locations) |
| Trial ID | NCT05728502 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from individuals in China diagnosed with chronic heart failure with reduced ejection fraction (HFrEF) who are receiving vericiguat treatment. The study aims to evaluate how well vericiguat works and its safety in a real-world setting by comparing the outcomes of patients on vericiguat with those receiving standard of care treatment. Participants must be at least 18 years old and have experienced a recent decompensation episode related to their heart failure. The study does not involve any specific interventions beyond routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with HFrEF who are naïve to vericiguat treatment and have had a recent decompensation episode.
Not a fit: Patients who have previously received vericiguat or are participating in other investigational programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of vericiguat for patients with HFrEF.
How similar studies have performed: Other studies have shown success with similar observational approaches, but this specific study focuses on vericiguat in a unique population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Multiple Locations, Many Locations
- Chinese Registries — Multiple Locations, Many Locations, China (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.