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Outcome Measures

Primary Outcomes (1)

Percent Change From Baseline in LVESVI (Left Ventricular End-systolic Volume Index) at Month 6
Percent change from baseline in LVESVI at Month 6 is presented. LVESVI is considered one of the standard echocardiography (ECHO) markers for assessing risks in ischemic heart failure (HF). The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 6

Secondary Outcomes (40)

Number of Treatment Emergent Adverse Events (TEAEs)
Up to 12 months
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Up to 12 months
Number of Participants With Abnormalities in Clinically Relevant Laboratory Assessments
At month 6
Number of Participants With Clinically Relevant Laboratory Abnormalities in Vital Signs Parameters
At month 12
Number of Participants With Clinically Relevant Laboratory Abnormalities in ECG Parameters
At month 12
+35 more secondary outcomes

Study Arms (3)

CDR132L 5 mg

EXPERIMENTAL

CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57

Drug: CDR132L

CDR132L 10 mg

EXPERIMENTAL

CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57

Drug: CDR132L

Placebo

PLACEBO COMPARATOR

Placebo intravenous in single dose on Day 1, Day 29 and Day 57

Drug: Placebo to CDR132L

Interventions

CDR132LDrug

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.

CDR132L 10 mgCDR132L 5 mg

Placebo to CDR132LDrug

Eligibility Criteria

Age30 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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.

Study Sites (49)

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

Göttingen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Related Publications (1)

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 Jul;32(7):2654-2661. doi: 10.1038/s41591-026-04408-4. Epub 2026 May 10.

PMID: 42108271DERIVED

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

Pharmacy staff is unblinded. They will hand-over prepared investigational medicinal product (IMP) in light-protected syringe.

Purpose

TREATMENT

Intervention Model

PARALLEL

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (40)

Study Arms (3)

CDR132L 5 mg

CDR132L 10 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (49)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (40)

Study Arms (3)

CDR132L 5 mg

CDR132L 10 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (49)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Documents

Locations