This clinical trial is focused on studying the effects of a medication called Vericiguat (also known by its code name MK-1242) in people with a condition known as Chronic Heart Failure With Reduced Ejection Fraction. This condition occurs when the heart muscle doesn’t pump blood as well as it should, which can lead to symptoms like shortness of breath and fatigue. The purpose of the study is to evaluate how effective Vericiguat is in reducing the risk of cardiovascular death or hospitalization due to heart failure.
Participants in the study will be randomly assigned to receive either Vericiguat or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will monitor participants over a period to see if Vericiguat helps in reducing the occurrence of serious heart-related events. The medication is taken orally, meaning it is swallowed in the form of a tablet.
The study aims to gather information on the time it takes for participants to experience their first heart-related event, such as cardiovascular death or hospitalization due to heart failure. It will also look at other outcomes, including the total number of hospitalizations and any side effects experienced by participants. The study is expected to continue until mid-2025, providing valuable insights into the potential benefits of Vericiguat for individuals with this type of heart failure.
1initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as a history of chronic heart failure and certain heart function measurements.
Participants are informed about the study’s purpose, procedures, and potential risks. Consent is obtained to ensure understanding and agreement to participate.
2randomization
Participants are randomly assigned to receive either the study medication, vericiguat, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.
This process ensures that the study results are unbiased and reliable.
3medication administration
Participants take the assigned tablet orally. The dosage may vary, with options including 2.5 mg, 5 mg, or 10 mg tablets.
The medication is taken once daily, and the duration of administration continues throughout the study period.
4regular follow-up visits
Regular follow-up visits are scheduled to monitor health status and any changes in condition. These visits help assess the effectiveness and safety of the treatment.
During these visits, participants may undergo various assessments, including heart function tests and blood tests.
5reporting of events
Participants are asked to report any health changes or side effects experienced during the study. This information is crucial for evaluating the safety of the treatment.
Both serious and non-serious events are documented to ensure comprehensive safety monitoring.
6end of study
The study concludes on the estimated end date, which is June 15, 2025. Participants may have a final visit to assess their health status and discuss any further steps.
The results of the study will contribute to understanding the effectiveness of vericiguat in reducing the risk of cardiovascular death or heart failure hospitalization.
Who Can Join the Study?
Must have a history of chronic heart failure with symptoms classified as New York Heart Association (NYHA) Class II to IV. This means the patient has ongoing heart failure with varying levels of symptoms.
Must be on guideline-directed medical therapy for heart failure, which means following a treatment plan recommended by medical guidelines.
No hospital visits for heart failure in the last 6 months or use of intravenous (IV) diuretics as an outpatient in the last 3 months before joining the study.
Must have a left ventricular ejection fraction (LVEF) of 40% or less. This is a measure of how well the heart pumps blood, assessed within the last 12 months using any imaging method.
Must have elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), which is a marker in the blood that indicates heart stress.
Female participants must not be pregnant or breastfeeding. If they are of childbearing potential, they must agree to use contraception during the study and for at least 1 month after the last dose of the study medication.
Both male and female participants are eligible to join the study.
Who Cannot Join the Study?
Patients who have a different type of heart failure than Chronic Heart Failure With Reduced Ejection Fraction cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of severe allergic reactions to the study medication cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.
Vericiguat is a medication being studied for its potential to help people with chronic heart failure. Heart failure is a condition where the heart doesn’t pump blood as well as it should. Vericiguat works by helping the blood vessels relax and widen, which can improve blood flow and reduce the strain on the heart. This medication is being tested to see if it can lower the risk of serious heart problems, like heart-related death or the need to be hospitalized because of heart failure.
Chronic Heart Failure With Reduced Ejection Fraction – This condition occurs when the heart muscle is unable to pump blood effectively, leading to a decrease in the amount of blood ejected from the heart with each beat. Over time, the heart’s ability to pump diminishes, causing blood to back up in the veins and fluid to accumulate in the lungs and other parts of the body. Symptoms often include shortness of breath, fatigue, and swelling in the legs and ankles. As the disease progresses, these symptoms may worsen, and patients may experience difficulty performing daily activities. The heart’s reduced pumping capacity can lead to further complications, affecting overall health and quality of life.
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