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Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack

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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 new treatment called CDR132L in patients who have experienced a heart attack, also known as a myocardial infarction. After a heart attack, some patients have a condition where the heart's left side does not pump blood as well as it should, which is referred to as a reduced left ventricular ejection fraction (LVEF). This study aims to evaluate the safety and effectiveness of CDR132L in improving heart function in these patients.

The study involves three groups of participants. One group will receive a low dose of CDR132L, another group will receive a higher dose, and the third group will receive a placebo. The treatment is given through an intravenous infusion, which means it is administered directly into the bloodstream. Participants will receive three doses, each given 28 days apart. The study will monitor changes in heart function and overall health over a period of time to determine the impact of the treatment.

Throughout the study, participants will undergo various health assessments, including heart imaging tests and blood tests, to track their progress. The goal is to see if CDR132L can help improve heart function and reduce symptoms associated with heart failure after a heart attack. The study will also keep track of any side effects or health changes experienced by participants to ensure the treatment is safe.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to sign an informed consent form. This marks the beginning of your participation in the clinical trial.

  2. Step 2

    Screening period

    During the screening period, your eligibility for the study will be confirmed. This includes checking your age, medical history, and specific health conditions such as a recent heart attack and reduced heart function.

  3. Step 3

    Randomization

    If eligible, you will be randomly assigned to one of three groups. Two groups will receive different doses of the study medication CDR132L, and one group will receive a placebo. This process ensures that the study results are unbiased.

  4. Step 4

    Medication administration

    You will receive the study medication or placebo through an intravenous infusion, which means it will be given directly into your vein. The doses will be administered three times, each 28 days apart. The doses of CDR132L will be either 5 mg/kg or 10 mg/kg, depending on your group.

  5. Step 5

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits will include physical exams, heart function tests, and blood tests to check for any changes or side effects.

  6. Step 6

    End of study assessments

    At the end of the study, final assessments will be conducted to evaluate the overall effects of the treatment on your heart function and general well-being.

Who can join the trial?

7 criteria

  • Patients must be male or female and aged between 30 to 80 years at the time of signing the consent form.
  • Patients must have experienced a spontaneous acute myocardial infarction (AMI), which is a type of heart attack, and must be randomized within 14 days of diagnosis.
  • Patients must have a left ventricular ejection fraction (LVEF) of 45% or less, as measured by an echocardiogram (ECHO) after the heart attack. LVEF is a measure of how well the heart is pumping blood.
  • Patients with a history of previous heart attacks can participate.
  • Patients must have a body weight of 120 kg or less.
  • Patients must have a N-terminal pro B-type natriuretic peptide (NT-proBNP) level between 125 pg/ml and 8000 pg/ml at screening. NT-proBNP is a blood test that helps assess heart function.
  • Patients must have had a STEMI or NSTEMI heart attack and undergone a procedure called percutaneous coronary intervention for this event. STEMI and NSTEMI are types of heart attacks, and percutaneous coronary intervention is a procedure to open blocked heart arteries.

Who cannot join the trial?

4 criteria

  • Patients who have had a recent myocardial infarction (heart attack) or are experiencing acute heart failure on the left side of the heart cannot participate.
  • Patients with a reduced LVEF (left ventricular ejection fraction) of 45% or less after a heart attack are not eligible. LVEF is a measure of how well the heart is pumping blood.
  • Patients who are not receiving standard care treatment for their condition cannot participate.
  • Patients who are part of a vulnerable population, which may include those with certain health conditions or social circumstances, are excluded.
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Investigated drugs

CDR132L is an experimental medication being tested in this clinical trial. It is designed to help patients who have a weakened heart function after a heart attack. The medication is given through an intravenous (IV) infusion, which means it is delivered directly into the bloodstream. The goal of CDR132L is to improve the heart's ability to pump blood by targeting specific molecules in the body that affect heart function. This medication is being studied to see if it can be a helpful addition to the standard treatments that patients are already receiving for their heart condition.

What is already known about the treatment

CDR132L – CDR132L is administered through an intravenous (IV) injection, given in three single doses, each 28 days apart. It is currently being studied in a Phase 2 clinical trial to evaluate its effectiveness and safety in patients who have experienced a heart attack and have reduced heart function, specifically a left ventricular ejection fraction of 45% or less. The main therapeutic use of CDR132L is to improve heart function in these patients. At the molecular level, CDR132L works by targeting specific molecules involved in heart muscle repair and function, although the exact mechanism is still under investigation. It is classified as an investigational drug, meaning it is still being studied and is not yet approved for general medical use.

Investigated diseases

  • Acute Myocardial Infarction

    This condition occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. It is commonly known as a heart attack. The blockage is usually caused by a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. As the plaque breaks, a blood clot forms, obstructing the blood flow. The affected heart muscle becomes deprived of oxygen, leading to tissue damage. Over time, this can weaken the heart's ability to pump blood effectively.

  • Left-Sided Heart Failure

    This condition happens when the left side of the heart cannot pump blood efficiently, leading to a buildup of fluid in the lungs. It is often a result of damage to the heart muscle, such as from a heart attack or long-term high blood pressure. As the left ventricle fails to pump blood out to the body, pressure increases in the left atrium and then in the pulmonary veins. This pressure causes fluid to leak into the lung tissues, leading to congestion and breathing difficulties. Over time, the heart may become enlarged as it works harder to meet the body's demands. This condition can lead to fatigue and reduced ability to exercise.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507569-24-00Protocol codeCDR132L-P2-01Estimated enrolment280 patientsSponsorCardior Pharmaceuticals GmbH

sourced from the EU Clinical Trials Register and site verification

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