This clinical trial is focused on studying a condition known as Heart Failure with Reduced Ejection Fraction, which is a type of heart failure where the heart muscle does not contract effectively, and less oxygen-rich blood is pumped out to the body. The study will evaluate a treatment called Omecamtiv Mecarbil, which is taken as a film-coated tablet. This medication is being tested to see if it can help improve heart function in patients with this type of heart failure.
The purpose of the study is to assess how effective Omecamtiv Mecarbil is compared to a placebo in reducing the risk of heart failure outcomes in patients who are already receiving standard heart failure treatments. Participants in the study will be randomly assigned to receive either the medication or a placebo. The study will be conducted over a period of time, and participants will take the medication orally.
Throughout the study, researchers will monitor participants to see if the medication helps reduce the occurrence of serious heart-related events, such as heart failure hospitalizations or cardiovascular death. The study aims to provide valuable information on whether Omecamtiv Mecarbil can be a beneficial treatment option for people with severe heart failure.
1joining the study
Upon joining the study, you will be randomly assigned to receive either the study medication, omecamtiv mecarbil, or a placebo. A placebo is a tablet that looks like the study medication but does not contain the active ingredient.
The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.
2medication administration
You will take the assigned medication orally in the form of a film-coated tablet. The exact dosage and frequency will be provided by the study team based on your specific needs and the study protocol.
It is important to take the medication as directed and report any side effects or concerns to the study team immediately.
3regular check-ups
Throughout the study, you will have regular check-ups with the study team. These visits are crucial for monitoring your health and the effects of the medication.
During these visits, various tests and assessments will be conducted to evaluate your heart function and overall health.
4reporting symptoms
You will be asked to keep track of any symptoms or changes in your health. This information is vital for understanding how the medication affects you.
The study team will provide you with a diary or other tools to help you record this information accurately.
5end of study participation
At the end of your participation in the study, you will have a final visit with the study team. This visit will include a comprehensive assessment of your health and a discussion of your experience during the study.
The study team will also provide information on any next steps or follow-up care that may be necessary.
Who Can Join the Study?
Must be an adult between the ages of 18 and 85.
Have a history of chronic Heart Failure with Reduced Ejection Fraction (HFrEF), which means the heart is not pumping as well as it should, and have been receiving treatment for at least 3 months.
Currently taking oral loop diuretics, which are medications that help remove excess fluid from the body.
If the patient does not have Atrial Fibrillation (AFF) on the screening ECG (a test that records the heart’s electrical activity):
Have a Left Ventricular Ejection Fraction (LVEF) of less than 30% within 6 months of screening. LVEF is a measurement of how much blood the left ventricle of the heart pumps out with each contraction.
Have elevated levels of a heart-related protein called N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) of 1000 pg/mL or more, or BNP of 300 pg/mL or more.
If the patient has Atrial Fibrillation (AFF) on the screening ECG:
Have a Left Ventricular Ejection Fraction (LVEF) of less than 25% within 6 months of screening.
Have elevated levels of N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) of 3000 pg/mL or more, or BNP of 900 pg/mL or more.
Not currently taking digoxin, a medication used to treat heart conditions.
Currently hospitalized primarily for heart failure, or have had a heart failure event within 6 months prior to screening.
Have been on standard heart failure therapies as per local guidelines for at least 30 days before screening.
Have a systolic blood pressure (the top number) of 130 mmHg or less and a diastolic blood pressure (the bottom number) of 90 mmHg or less.
Who Cannot Join the Study?
Patients with a history of severe allergic reactions to the study medication or its ingredients cannot participate.
Patients who have had a heart attack in the last 90 days are not eligible.
Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication, cannot join the study.
Patients with severe kidney disease, which means their kidneys are not working well, are excluded.
Patients with severe liver disease, meaning their liver is not functioning properly, cannot participate.
Patients who are currently participating in another clinical trial are not eligible.
Pregnant or breastfeeding women cannot join the study.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate are excluded.
Omecamtiv Mecarbil is a medication being studied for its potential to help people with heart failure, a condition where the heart doesn’t pump blood as well as it should. This medication works by helping the heart muscle contract more effectively, which may improve the heart’s ability to pump blood throughout the body. The goal of using omecamtiv mecarbil in this trial is to see if it can reduce the risk of heart failure-related problems in patients who have a severely reduced ejection fraction, meaning their heart’s pumping ability is significantly impaired. This study is being conducted alongside standard treatments for heart failure to see if adding omecamtiv mecarbil can provide additional benefits.
Heart Failure With Reduced Ejection Fraction – Heart Failure With Reduced Ejection Fraction (HFrEF) is a condition where 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. This condition often results from damage to the heart muscle, such as from a heart attack or chronic high blood pressure. As the disease progresses, the heart becomes weaker and less efficient, causing symptoms like shortness of breath, fatigue, and fluid retention. Over time, the heart’s reduced ability to pump blood can lead to a buildup of fluid in the lungs and other parts of the body. Patients may experience worsening symptoms during physical activity or when lying down. The progression of HFrEF can lead to frequent hospitalizations and a decline in quality of life.
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