Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction

Summary

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.

Timeline

Start

2022-07-07

Primary completion

2024-09-26

Completion

2025-03-17

Outcome

Missed primary endpoint

paper The primary endpoint-the percentage change in LV end-systolic volume index at 6 months-improved in all groups but did not differ significantly PMID 42108271 ↗

Publications

• 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.

Drugs

Indications