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NCT06195930 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT06195930 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 106 participants.
The verdict
NCT06195930, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction. Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is too weak to pump enough blood to the rest of the body. This results in a reduced supply of the oxygen that the body requires to function properly. The common symptoms of HFrEF include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays or even death. Vericiguat is an approved drug for use in people with chronic HFrEF. It works by activating a protein called soluble guanylate cyclase, which helps dilating the blood vessels and in turn improves heart function. Currently, treatment with vericiguat starts at a daily dose of 2.5 milligrams (mg), which increases to 5 mg after 2 weeks. The dose is then increased to the target dose of 10 mg after another 2 weeks. In this study, researchers are trying to learn how well participants can tolerate and how safe it is to start vericiguat at a dose of 5 mg. Starting directly at the 5 mg dose is expected to help reach the target dose of 10 mg faster. Participants will take vericiguat 5 mg as a tablet by mouth once daily along with their regular heart medications. At the start of the study, study doctors will check participants' medical history and perform full health check-ups to confirm if they can take part in the study. Throughout the study, study doctors will monitor participants' previous and current medications, their heart health, and their overall well-being. This will help researchers assess how safe the study drug is and if they experience adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related
Interventions
- DRUG Vericiguat (BAY1021189) 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2024-07-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06195930
The ClinicalTrials.gov registry entry for NCT06195930 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 106 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 (BAY1021189) 5 mg is the first listed.
NCT06195930 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06195930 about?
NCT06195930 is a clinical study titled "A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction". Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction. Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is too weak to pump enough blood to the rest of the body. This resu...
What is the current status of trial NCT06195930?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2024-04-18. Estimated completion is 2024-07-29.
What interventions are being tested in trial NCT06195930?
The interventions under investigation include: Vericiguat (BAY1021189) 5 mg (DRUG).
Who is sponsoring clinical trial NCT06195930?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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