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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
294
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.
Placebo to CDR132L
Institut klinicke a experimentalni mediciny
Prague, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, Czechia
St. Marien-Krankenhaus Ahaus
Ahaus, Germany
Herzzentrum Dresden Universitätsklinik
Dresden, Germany
Helios Klinikum Erfurt
Erfurt, Germany
Universitätsmedizin Göttingen
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.
Time frame: 6 months
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Göttingen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
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