This clinical trial is focused on studying a condition known as chronic heart failure with reduced ejection fraction. This is a type of heart failure where the heart muscle does not pump blood as well as it should. The study is testing a medication called Tovinontrine, which is a small molecule inhibitor of an enzyme called phosphodiesterase type 9 (PDE9). This medication is being tested in tablet form and is taken orally. The purpose of the study is to assess the safety and effectiveness of Tovinontrine in patients with this type of heart failure.
Participants in the study will be randomly assigned to receive either Tovinontrine or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will last for 12 weeks, during which time the effects of the medication on certain heart-related markers in the blood will be monitored. These markers include NT-proBNP, a substance that is often elevated in heart failure, and cGMP, which is related to heart function. The study aims to find the best dose of Tovinontrine that can help improve these markers.
Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving Tovinontrine and who is receiving the placebo. This helps ensure that the results are unbiased and reliable. The ultimate goal is to determine if Tovinontrine can be a safe and effective treatment option for people with chronic heart failure with reduced ejection fraction.
1randomization and initial assessment
Upon joining the study, the patient is randomly assigned to receive either tovinontrine or a placebo. This process is double-blind, meaning neither the patient nor the researchers know which treatment the patient receives.
An initial assessment is conducted to establish baseline measurements. This includes measuring levels of NT-proBNP, a marker related to heart failure.
2medication administration
The patient begins taking the assigned medication, which could be tovinontrine or a placebo, in the form of an immediate-release tablet.
The medication is taken orally twice daily (BID). The exact dosage is determined as part of the study’s dose-finding objective.
3ongoing monitoring and assessments
Throughout the 12-week study period, the patient undergoes regular monitoring to assess the safety and effectiveness of the treatment.
This includes periodic measurements of NT-proBNP levels, as well as other markers such as urine and plasma cGMP, and BNP levels.
4final assessment
At the end of the 12-week period, a final assessment is conducted to evaluate changes from the baseline measurements.
The primary focus is on the percent change in NT-proBNP levels, with secondary assessments including changes in other markers and quality of life measures.
Who Can Join the Study?
The patient must be an adult, which means they are at least 18 years old or the adult age according to their country’s guidelines.
The patient should have a medical history that supports a diagnosis of heart failure (HF) syndrome, specifically classified as NYHA functional class II to III. This means the patient has moderate symptoms of heart failure and has had these symptoms for at least 6 months before the screening.
The patient must have an ejection fraction (EF) of 40% or less. Ejection fraction is a measurement of how well the heart is pumping blood, and this is checked using a test called a transthoracic echocardiogram (TTE).
The patient should have a level of NT-proBNP of at least 600 pg/mL at the time of screening. NT-proBNP is a substance in the blood that can indicate heart failure. If the patient has a condition called atrial fibrillation or flutter, their NT-proBNP level should be at least 1000 pg/mL.
The patient must be on stable and optimized doses of heart failure therapy as recommended by guidelines. This means their treatment should be consistent and adjusted to the best possible level according to the doctor’s judgment.
The patient should not have started any new heart failure treatments, except for diuretics, in the 3 months before screening or during the screening period. Their treatment should be stable for at least 4 weeks before screening and during the screening period, with no planned changes after they are randomly assigned to a treatment group.
Other specific criteria defined in the study protocol may also apply.
Who Cannot Join the Study?
Patients who do not have heart failure with reduced ejection fraction (HFrEF). This is a condition where the heart doesn’t pump blood as well as it should.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Tovinontrine is a medication being studied for its potential to help patients with chronic heart failure with reduced ejection fraction. The trial aims to determine how effective and safe tovinontrine is by measuring its impact on a specific heart-related protein in the blood over a period of 12 weeks.
Heart Failure with Reduced Ejection Fraction (HFrEF) – This condition occurs when the heart muscle is unable to pump blood effectively, leading to a reduced ejection fraction, which is a measure of how much blood the left ventricle pumps out with each contraction. Over time, the heart becomes weaker, and symptoms such as shortness of breath, fatigue, and fluid retention may develop. The progression of HFrEF can lead to worsening heart function and increased difficulty in performing daily activities. The heart’s inability to pump efficiently can cause blood to back up in the lungs and other parts of the body, leading to congestion and swelling. As the condition advances, patients may experience more frequent hospitalizations and a decline in quality of life.
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