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NCT06363110 · ClinicalTrials.gov registry record
An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 1,400
- Enrollment target
NCT06363110 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 1,400 participants.
The verdict
NCT06363110 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 1,400 participants
- Enrollment target
Study Summary
This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied. In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare. Chronic HFrEF is a long-term condition in which the heart becomes weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen, which the body requires to function properly. The study treatment, vericiguat, works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow. As a result, the heart can pump better. It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment. The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors. The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat: * starting dose of vericiguat * daily changes in dosage pattern * time taken to reach the target dose * number and percentage of participants: * with specific changes in dosage pattern * reaching the target dose of vericiguat They will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF. The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericigu
Interventions
- DRUG Vericiguat (Verquvo, BAY1021189)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,400 participants |
| Start Date | 2024-04-10 |
| Est. Completion | 2024-06-24 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06363110
The ClinicalTrials.gov registry entry for NCT06363110 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vericiguat (Verquvo, BAY1021189) is the first listed.
NCT06363110 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06363110 about?
NCT06363110 is a clinical study titled "An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States". This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied. In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare. Chronic HFrEF is a...
What is the current status of trial NCT06363110?
This trial is currently completed. The enrollment target is 1,400 participants. The study started on 2024-04-10. Estimated completion is 2024-06-24.
What interventions are being tested in trial NCT06363110?
The interventions under investigation include: Vericiguat (Verquvo, BAY1021189) (DRUG).
Who is sponsoring clinical trial NCT06363110?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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