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Study on the Effects of Trimetazidine on Heart Failure with Preserved Ejection Fraction in Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Trimeductan MR, which contains the active ingredient trimetazidine dihydrochloride. The study is investigating its impact on people with a type of heart condition known as heart failure with preserved ejection fraction (HFpEF). This condition occurs when the heart's lower chambers are unable to fill properly with blood, even though the heart's pumping ability is normal. The purpose of the study is to assess how this medication affects the heart and related health markers.

Participants in the study will receive either the Trimeductan MR medication or a placebo, which looks like the medication but does not contain the active ingredient. The study will monitor participants over a period of time to observe any changes in their health, particularly focusing on the time it takes for participants to be hospitalized or experience serious health events related to their heart condition. The study aims to gather information on how the medication might improve heart function and overall health outcomes for those with HFpEF.

Throughout the study, various health indicators will be measured, including heart function and levels of certain substances in the blood that are linked to heart health and inflammation. These measurements will help researchers understand the potential benefits of Trimeductan MR for people with HFpEF. The study is expected to continue until the end of 2027, providing valuable insights into the treatment of this heart condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to sign an informed consent form. This form confirms your willingness to participate and that you understand the details of the study.
Step 2
Initial assessment
You will undergo an initial assessment to confirm your eligibility. This includes checking your age, which should be between 55 and 85 years, and your heart condition, specifically heart failure with preserved ejection fraction (HFpEF).
Your heart's ejection fraction will be measured using an echocardiogram to ensure it is 50% or higher. Additionally, your hsCRP level, a marker of inflammation, will be checked to ensure it is 1.5 mg/L or higher.
Step 3
Medication administration
If eligible, you will be assigned to take either the medication Trimeductan MR or a placebo. The medication is a modified-release tablet containing trimetazidine dihydrochloride, taken orally.
The dosage is 35 mg, and you will take it as directed by the study team. The frequency and duration of administration will be specified by the study protocol.
Step 4
Regular follow-ups
Throughout the study, you will have regular follow-up visits. These visits will monitor your health, heart function, and any side effects from the medication.
You will be assessed for any hospitalizations or changes in your heart condition. Your quality of life and heart function will be evaluated using specific questionnaires and tests.
Step 5
End of study
The study is expected to end by December 31, 2027. At the end of the study, a final assessment will be conducted to evaluate your overall health and the impact of the medication on your heart condition.

Who can join the trial?

7 criteria

Express willingness to participate in the study and sign the informed consent form after receiving information about the study.
Be between the ages of 55 and 85 years at the start of the study.
Have a NYHA Class I to III classification at the last screening assessment. This is a way to describe the severity of heart failure symptoms, with Class I being mild and Class III being more severe.
Have a documented diagnosis of Heart Failure with Preserved Ejection Fraction (HFpEF) or a new diagnosis based on a specific score called HFA-PEFF score ≥ 5 by a heart doctor during the screening phase.
Have a Left Ventricular Ejection Fraction (LVEF) ≥ 50% on an echocardiographic screening. This is a measure of how well the heart is pumping blood.
No changes in heart failure medication for at least 3 months before the screening.
Have a high-sensitivity C-reactive protein (hsCRP) level ≥ 1.5 mg/L. This is a blood test that measures inflammation in the body.

Who cannot join the trial?

8 criteria

Patients with a history of severe allergic reactions to any of the study medications cannot participate.
Patients who have had a heart attack in the last 3 months 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, meaning 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 take part in the study.
Patients with any other serious medical condition that might interfere with the study results are excluded.

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Verified sites

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Copernicus Podmiot Leczniczy Sp. z o.o.
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Gdansk, Poland
Uniwersyteckie Centrum Kliniczne
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Gdansk, Poland
Uniwersyteckie Centrum Medycyny Morskiej I Tropikalnej
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Gdynia, Poland

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Investigated drugs

Trimetazidine is a medication used in this clinical trial. It is designed to help improve the function of the heart and blood vessels. Trimetazidine works by increasing the efficiency of the heart's energy use, which can help improve symptoms in people with heart failure. In this trial, researchers are studying how trimetazidine affects the health of blood vessels and certain markers in the blood that are linked to heart failure. The goal is to see if trimetazidine can help reduce the risk of hospitalization or death in people with heart failure who have a normal pumping function of the heart.

Trimetazidine Dihydrochloride

What is already known about the treatment

Trimetazidine – Trimetazidine is administered orally in the form of tablets. It is currently being studied for its effects on heart failure with preserved ejection fraction, a condition where the heart's pumping ability is normal, but it struggles to fill with blood. The main therapeutic indication for trimetazidine in this context is to improve heart function and reduce the risk of hospitalization or death. At the molecular level, trimetazidine works by optimizing the energy production in heart cells, helping them function more efficiently under stress. It is classified as a metabolic agent, which means it helps improve the metabolism of heart cells.

Investigated diseases

Heart failure with preserved ejection fraction – This condition occurs when the heart's lower chambers, or ventricles, are unable to fill properly with blood during the diastolic phase, despite the heart's ability to pump blood effectively. The heart muscle becomes stiff, leading to increased pressure in the heart and lungs. Over time, this can cause symptoms such as shortness of breath, fatigue, and fluid retention, particularly in the legs and abdomen. The disease progresses as the heart's ability to relax and fill with blood continues to decline, exacerbating symptoms. Patients may experience episodes of worsening symptoms, known as exacerbations, which can lead to hospitalization. The condition is often associated with other health issues like high blood pressure, obesity, and diabetes.