New drug aims to heal hearts after attack – trial results awaited
NCT ID NCT05350969
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tested a new medicine called CDR132L in 294 people who had a recent heart attack and had weak heart pumping (ejection fraction 45% or less). Participants received one of two doses of CDR132L or a placebo, added to standard care, for 6 months. The goal was to see if the drug safely improves heart function and reduces heart failure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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294 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria: 1. Male or female patients, aged ≥ 30 to ≤ 80 years at the date of signing informed consent which is defined as the beginning of the Screening Period. 2. Spontaneous acute mycardial infarction (AMI) (type I) based on the universal MI definition with randomization to occur no later than 14 days after index event diagnosis. 3. Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI). 4. Patient with previous MI events in history can be included. 5. Patient with body weight of ≤ 120 kg. 6. N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and \< 8000 pg/ml at screening. 7. Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention for this event. Exclusion Criteria: 1. A woman of childbearing potential (WOCBP). 2. Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy. 3. Patient with New York Heart Association (NYHA) class IV at screening or randomization. 4. Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period. 5. Patient has severe valvular heart disease. 6. Patient has systolic BP \< 90 mmHg or \> 180 mmHg, diastolic BP \< 50 mmHg or \> 110 mmHg, and/or heart rate \< 50 or \> 100 beats/minute at screening or randomization. 7. Patient with an estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or on dialysis. 8. Patient with hepatic insufficiency classified as Child-Pugh B or C. 9. Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis. 10. Patient has medical history of bleeding disorders or has thrombocytopenia (platelets \< 100,000/μL). 11. Patient has poorly controlled diabetes as determined by the Investigator. 12. Patient has a history or presence of any of the following cardiac conditions: known structural cardiac abnormalities beyond HF, family history of long QT syndrome, cardiac syncope, or recurrent, idiopathic syncope. 13. Any clinically significant abnormalities, at the discretion of the Investigator, in rhythm, conduction, or morphology of resting ECG that pose an additional safety risk to patients. 14. Patient with active "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening. 15. Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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"Alexandra" General Hospital of Athens
Athens, Greece
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"Attikon" General University Hospital
Athens, Greece
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Complejo Hospitalario Universitario de Vigo
Vigo, Spain
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D & A Research B.V.
Sneek, Netherlands
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Deventer Ziekenhuis
Deventer, Netherlands
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Erasmus University Medical Center
Rotterdam, Netherlands
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Gabinet Internistyczno-Kardiologiczny Jacek Nowak
Libiąż, Poland
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Gelderse Vallei Ziekenhuis
Ede, Netherlands
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Gelre Ziekenhuizen
Zutphen, Netherlands
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General University Hospital of Patras "Panagia i Voitheia"
Pátrai, Greece
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Helios Klinikum Erfurt
Erfurt, Germany
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Herzzentrum Dresden Universitätsklinik
Dresden, Germany
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Hospital Clinico Universitario de Valencia
Valencia, Spain
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Hospital Universitari Germans Trias i Pujol
Badalona, Spain
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Hospital Universitario La Paz
Madrid, Spain
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Hospital Universitario San Cecilio
Granada, Spain
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Hospital Universitario Virgen Macarena
Seville, Spain
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Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
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Hospital Universitario de Sabadell
Sabadell, Spain
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Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
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Ikazia Ziekenhuis
Rotterdam, Netherlands
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Institut klinicke a experimentalni mediciny
Prague, Czechia
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Investigational Site
Wroclaw, Poland
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Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch
's-Hertogenbosch, Netherlands
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Klinikum Ludwigshafen
Ludwigshafen, Germany
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Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, Poland
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Medicome Sp. z o.o.
Oświęcim, Poland
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Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
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Medizinische Hochschule Hannover
Hanover, Germany
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NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog
Sopot, Poland
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NZOZ SALUS JZ Peruga
Lodz, Poland
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One wojskowy Szpital Kliniczny w Lublinie
Lublin, Poland
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Polsko Amerykanskie Kliniki Serca
Kędzierzyn-Koźle, Poland
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Queen Elizabeth University Hospital
Glasgow, United Kingdom
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Richmond Pharmacology Limited
London, United Kingdom
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Semmelweis University
Budapest, Hungary
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Slingeland Ziekenhuis
Doetinchem, Netherlands
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South Tees Hospital NHS Foundation Trust
Middlesbrough, United Kingdom
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Spec.Szpital im.dr Sokolowskiego
Wałbrzych, Poland
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Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego
Kielce, Poland
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St. Jansdal Ziekenhuis
Lelystad, Netherlands
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St. Marien-Krankenhaus Ahaus
Ahaus, Germany
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Universitätsklinikum Schleswig-Holstein
Kiel, Germany
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Universitätsklinikum Würzburg
Würzburg, Germany
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Universitätsmedizin Göttingen
Göttingen, Germany
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Všeobecná fakultní nemocnice v Praze
Prague, Czechia
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Wojewodzki Szpital Zespolony
Torun, Poland
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Wojewódzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, Poland
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Wycombe Hospital
High Wycombe, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can yoga classes rival standard rehab for a failing heart?
- Heart failure drug probed for hidden benefit on lung pressure
- Can a heart rate drug keep heart failure patients out of the hospital?
- Can a power calculation reveal how failing hearts lose energy?
- Nerve-stimulating implant tested for easing heart failure symptoms