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
Study Details
Study Description
Brief Summary
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:
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high blood pressure
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any medical problems due to combination of the study treatment vericiguat with nitrates and nitric oxide (NO) donors or with PDE5 inhibitors
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medical problems in participants with liver problems or with reduced kidney function
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medical problems in participants with low blood pressure below <100 mmHg or with symptoms due to low blood pressure
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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:
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underlying and concomitant diseases,
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prior medication,
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treatment duration,
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laboratory parameters,
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vital signs,
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results of cardiac exams (e.g. cardiac ultrasound),
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heart failure related hospitalization events,
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| vericiguat arm Japanese patients with a diagnosis of chronic heart failure who received standard treatment and will start vericiguat therapy for chronic heart failure. |
Drug: Vericiguat (Verquvo, BAY1021189)
Dosage at the discretion of the treating physician, based on the recommendations written in the product information.
|
| control arm Japanese patients a diagnosis of chronic heart failure who received standard treatment and will continue standard of care treatment for chronic heart failure. |
Drug: Standard of care
Dosage at the discretion of the treating physician
|
Outcome Measures
Primary Outcome Measures
- Severity of Adverse Events (AEs) for vericiguat arm [Up to 2 years]
- Seriousness of Adverse Events (AEs) for vericiguat arm [Up to 2 years]
- Outcome of Adverse Events (AEs) for vericiguat arm [Up to 2 years]
- Causality assessment of Adverse Events (AEs) for vericiguat arm [Up to 2 years]
- Incidence of Cardiovascular (CV) death for vericiguat arm and control arm [Up to 2 years]
Definition of CV death is Heart failure, acute myocardial infarction, stroke (cerebral infarction, cerebral hemorrhage), sudden death, other CV deaths (e.g., pulmonary embolism, peripheral arterial disease), death of unknown cause
Secondary Outcome Measures
- The duration (days) of vericiguat treatment for vericiguat arm [Up to 2 years]
- The reason for ending vericiguat treatment/observation for vericiguat arm [Up to 2 years]
- Doseage and dose modification of vericiguat treatment for vericiguat arm [Up to 2 years]
- Systolic blood pressure and diastolic blood pressure for vericiguat arm [Up to 2 years]
- Pulse rate for vericiguat arm [Up to 2 years]
- Assessment of left ventricular end-diastolic volume index and left ventricular end-systolic volume index for vericiguat arm [Up to 2 years]
- Assessment of left ventricular ejection fraction for vericiguat arm [Up to 2 years]
- Assessment of Brain Natriuretic Peptide/N-terminal pro-Brain Natriuretic Peptide for vericiguat arm [Up to 2 years]
- Assessment of Serum creatinine for vericiguat arm [Up to 2 years]
- Assessment of e-GFR for vericiguat arm [Up to 2 years]
- Assessment of Hemoglobin for vericiguat arm [Up to 2 years]
- Assessment of Hematocrit for vericiguat arm [Up to 2 years]
- Assessment of New York Heart Association (NYHA) classification for vericiguat arm [Up to 2 years]
- Concomitant medications for vericiguat arm [Up to 2 years]
- All-cause mortality for vericiguat arm [Up to 2 years]
- Number of patients with Heart Failure (HF) hospitalization during observation period for vericiguat arm [Up to 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
vericiguat arm:
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Patients receiving standard treatment for chronic heart failure, and vericiguat will be treated in accordance with the package insert (no history of receiving vericiguat)
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Patients who gave written consent to this investigation
control arm:
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Patients receiving standard treatment for chronic heart failure according to the package insert of vericiguat as following (no history of receiving vericiguat)
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Prior (within 6 months) heart failure hospitalization or prior (within 3 months) intravenous (IV) diuretics for heart failure not requiring hospitalization
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N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) ≥1000 pg/mL or Brain Natriuretic Peptide (BNP) ≥192 pg/mL (sinus rhythm), NT-proBNP ≥1600 pg/mL or BNP ≥319 pg/mL (atrial fibrillation) as measured recently within a month.
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New York Heart Association (NYHA) Classification: Class II to Class IV
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Left ventricular ejection fraction (LVEF): less than 45%
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Patients who gave written informed consent to this study
Exclusion Criteria:
vericiguat arm:
- Patients who are participating in an interventional study
control arm:
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Patients who have started or are scheduled to start therapy with vericiguat for chronic heart failure
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Patients who are participating in an interventional study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Japanese registries | Multiple Locations | Many Locations | Japan |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21880