Vericiguat for Chronic Heart Failure in Japanese Patients
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
Recruiting
Observational Study
Chronic Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
1,400 (estimated)
Sponsor
Bayer · Industry
Who this trial is looking for
This trial is looking for Japanese people with chronic heart failure who are receiving treatment with a drug called vericiguat. Participants will be monitored for health issues while using vericiguat in real-world situations.
Are You a Good Fit for This Trial?
Must be takingStandard treatment for chronic heart failure
You may be able to join if
I have chronic heart failure.
I have not taken vericiguat before.
I agree to participate in this study.
You may not be able to join if
I am participating in another interventional study.
I have started or will start treatment with vericiguat for chronic heart failure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 a…
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.
Trial Locations
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Eligibility 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 recei…
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
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