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 to the study treatment. Access to study treatment after the end of this study is not planned. Everyone, including study doctors and participants, will know what drug the participants receive during the study. Participants may be in the study for about 4 weeks. Participants may not benefit from the treatment as the study is designed to assess safety and tolerability: the duration of the study is very short and participants will be taking a low dose of vericiguat without moving to the target dose of 10 mg during the study. However, the findings of this study may enable people with chronic HFrEF to safely skip one initial dosing step and reach the target dose of vericiguat faster. Participants may experience medical problems such as low blood pressure, upset stomach, nausea, dizziness, and headache. Researchers will monitor and manage all these, and other, medical problems participants may have during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Vericiguat (BAY1021189) will be taken as 5 mg tablet 1x daily over at least 14 days up to 18 days (+ 4 days time window allowed)
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Treatment Tolerability: Number of Participants Without Discontinuation of Study Intervention (Incl. Max. 1 Day Interruption) and Without Moderate to Severe Symptomatic Hypotension
Treatment tolerability, defined as the completion of the two-week 5 mg dose without discontinuation of study intervention (incl. max. 1 day interruption) and without moderate to severe symptomatic hypotension between Visit 1 and Visit 2
Time frame: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
Treatment Tolerability: Number of Participants Without Discontinuation of Study Intervention (Max. 2 Day Interruption Included) and Without Moderate to Severe Symptomatic Hypotension
Treatment tolerability, defined as the completion of the two-week 5 mg dose without discontinuation of study intervention (incl. max. 2 day interruption) and without moderate to severe symptomatic hypotension between Visit 1 and Visit 2
Time frame: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
Number of Participants With Any Adverse Event (AE) Reported Between Visit 1 and Visit 2
Any AE reported between Visit 1 and Visit 2 to describe the safety events of initiation of 5mg dose.
Time frame: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
Number of Participants With no AE Related to Study Intervention Between Visit 1 and Visit 2
Absence of AEs related to study intervention between Visit 1 and Visit 2 to describe safety events of initiation of 5mg dose.
Time frame: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
Number of Participants With Continuous Intake of Study Intervention Between Visit 1 and Visit 2 or Restart of Study Intervention After Any Temporary Interruption.
To further evaluate the tolerability of 5mg as a starting dose
Time frame: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
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