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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
D & A Research B.V. Sneek The Netherlands
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Ziekenhuis St Jansdal Harderwijk The Netherlands
Ikazia Ziekenhuis Rotterdam The Netherlands
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Wojewodzki Szpital Zespolony W Kielcach SPZOZ Kielce Poland
Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II Grodzisk Mazowiecki Poland
Hatvani Albert Schweitzer Korhaz-Rendelointezet Hatvan Hungary
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Coromed-Smo Kft. Pecs Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Alexandra Hospital Athens Greece
Semmelweis University Budapest Hungary
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
General University Hospital Of Patras Patras Greece
Deventer Ziekenhuis Deventer The Netherlands
American Heart Of Poland S.A. Kedzierzyn-Kozle Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Slingeland Ziekenhuis Doetinchem The Netherlands
Medifarma-98 Kft. Nyiregyhaza Hungary
Gelre Hospitals Zutphen The Netherlands
DermaMed Research Kft. Oroshaza Hungary
Ilgbwnaez Fud Cazumzwj Ahn Ezhycogehhmr Mdrvoaml Prague Czechia
Srpemuya Prbjenikg Suq z otmr Gdynia Poland
Cbrbmlcq Hboxumxbfdmu Uebsrtcnvaubc Dr Vdpg Vigo Spain
Pddpncissx Kgac Bekescsaba Hungary
Rhloe Hakwm Iidcnrhnvlyufghivaqdjmqrcpgswu Sokuwetngeqwsst Ghrfaiw Lvnxlbcx Libiąż Poland
Ehlkiqw Uryzjprwvzmw Minvwny Cgmpkel Rmmxpgdjq (efzcsew Mmv Rotterdam The Netherlands
Hoztewss Dk Lg Sdrmp Ckwd I Sqgo Per Barcelona Spain
Fhahvhsgl Puhq Lw Ihezfrtjdzbon Bmyoubjkn Dry Hqohihhh Uaxlyivhjjshj Li Pnp Madrid Spain
Hoxzesiy Uvnlgjjiuipgj Henztkgp Txxqf y Pzjupb Irvyiyzc Cwfdgq duntexnocnbxmqlxg (ypwt Badalona Spain
Nsdx Sakhgfzy Jcv Zmkluqpe Pkgqtj Pmlg Sywqo Lodz Poland
Wxzvojzrlu Smydehl Iyv Sfqgbwv Pdv W Prkbohjqn Przemysl Poland
Ukpddhinlg Gscdqgu Hdunojth Arlaqpz Athens Greece
Knxvyofjv Smzckkl Sqgyktonlzegivd id Jius Pgogm Ib Cracow Poland
Mjmhkuty Spi z ovae Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
27.06.2022
Germany Germany
Not recruiting
27.06.2022
Greece Greece
Not recruiting
27.06.2022
Hungary Hungary
Not recruiting
27.06.2022
Poland Poland
Not recruiting
27.06.2022
Spain Spain
Not recruiting
27.06.2022
The Netherlands The Netherlands
Not recruiting
27.06.2022

Trial locations

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.

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 ID:
2023-507569-24-00
Protocol code:
CDR132L-P2-01
NCT ID:
NCT05350969
Trial Phase:
Therapeutic exploratory (Phase II)

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