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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507569-24-00 | EU Trial (CTIS) Number | ||
| 2021-006040-27 | EudraCT Number |
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This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12.
Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDR132L 5 mg | Experimental | CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57 |
|
| CDR132L 10 mg | Experimental | CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57 |
|
| Placebo | Placebo Comparator | Placebo intravenous in single dose on Day 1, Day 29 and Day 57 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDR132L | Drug | CDR132L is a synthetic antisense oligonucleotide (ASO) and a selective inhibitor of microRNA-132-3p (miR-132). miR-132 in cardiomyocytes is a central switch affecting the expression of genes that are crucially involved in maladaptive cardiac remodeling, transformation, and pathological cardiac growth (hypertrophy), contributing to adverse cardiac remodeling and heart failure (HF).1-5 Aberrant expression of miR-132 in cardiac cells is causally associated with cardiac remodeling and HF progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiography (ECHO) | Percent change from baseline (screening to occur at least 3 days after MI diagnosis as measured by ECHO [central laboratory]) in Left Ventricular End-Systolic Volume (LVESVI) at Month 6. | 6 months |
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Main Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johann Bauersachs, Prof. Dr. | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut klinicke a experimentalni mediciny | Prague | Czechia | ||||
| Všeobecná fakultní nemocnice v Praze |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42108271 | Derived | Bauersachs J, Solomon SD, Anker SD, Antorrena-Miranda I, de Boer RA, Filippatos G, Friede T, Hauke W, Ponikowski P, Vardeny O, Altschul R, Gamborg M, Vinther K, Thum T. The microRNA inhibitor CDR132L in patients with reduced left ventricular ejection fraction after myocardial infarction: a randomized phase 2 trial. Nat Med. 2026 May 10. doi: 10.1038/s41591-026-04408-4. Online ahead of print. |
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Pharmacy staff is unblinded. They will hand-over prepared investigational medicinal product (IMP) in light-protected syringe.
|
| Placebo to CDR132L | Drug | Placebo to CDR132L |
|
| Prague |
| Czechia |
| St. Marien-Krankenhaus Ahaus | Ahaus | Germany |
| Herzzentrum Dresden Universitätsklinik | Dresden | Germany |
| Helios Klinikum Erfurt | Erfurt | Germany |
| Universitätsmedizin Göttingen | Göttingen | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | Germany |
| Klinikum Ludwigshafen | Ludwigshafen | Germany |
| Universitätsklinikum Würzburg | Würzburg | Germany |
| "Alexandra" General Hospital of Athens | Athens | Greece |
| "Attikon" General University Hospital | Athens | Greece |
| General University Hospital of Patras "Panagia i Voitheia" | Pátrai | Greece |
| Semmelweis University | Budapest | Hungary |
| Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch | 's-Hertogenbosch | Netherlands |
| Deventer Ziekenhuis | Deventer | Netherlands |
| Slingeland Ziekenhuis | Doetinchem | Netherlands |
| Gelderse Vallei Ziekenhuis | Ede | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Netherlands |
| St. Jansdal Ziekenhuis | Lelystad | Netherlands |
| Erasmus University Medical Center | Rotterdam | Netherlands |
| Ikazia Ziekenhuis | Rotterdam | Netherlands |
| D & A Research B.V. | Sneek | Netherlands |
| Gelre Ziekenhuizen | Zutphen | Netherlands |
| Polsko Amerykanskie Kliniki Serca | Kędzierzyn-Koźle | Poland |
| Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego | Kielce | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II | Krakow | Poland |
| Gabinet Internistyczno-Kardiologiczny Jacek Nowak | Libiąż | Poland |
| NZOZ SALUS JZ Peruga | Lodz | Poland |
| One wojskowy Szpital Kliniczny w Lublinie | Lublin | Poland |
| Medicome Sp. z o.o. | Oświęcim | Poland |
| Wojewódzki Szpital im. Sw. Ojca Pio w Przemyslu | Przemyśl | Poland |
| NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog | Sopot | Poland |
| Wojewodzki Szpital Zespolony | Torun | Poland |
| Spec.Szpital im.dr Sokolowskiego | Wałbrzych | Poland |
| Investigational Site | Wroclaw | Poland |
| Hospital Universitari Germans Trias i Pujol | Badalona | Spain |
| Hospital de la Santa Creu I Sant Pau | Barcelona | Spain |
| Hospital Universitario San Cecilio | Granada | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | Spain |
| Hospital Universitario de Sabadell | Sabadell | Spain |
| Hospital Universitario Virgen Macarena | Seville | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Spain |
| Queen Elizabeth University Hospital | Glasgow | United Kingdom |
| Wycombe Hospital | High Wycombe | United Kingdom |
| Richmond Pharmacology Limited | London | United Kingdom |
| South Tees Hospital NHS Foundation Trust | Middlesbrough | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2026 | May 26, 2026 | 20 | ||
| Jun 19, 2026 |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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