Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy

Sponsor
Cardior Pharmaceuticals GmbH
Study ID
NCT05953831
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Placebo — DRUG
    Placebo to CDR132L

Study Details

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study including approximately 130 randomized HF patients with heart failure with mildly reduced or preserved ejection fraction (LVEF ≥45%), to assess efficacy and safety of CDR132L on reverse remodeling. In this study, patients with HFpEF (EF ≥50%) or HFmrEF (LVEF 45-49%) will be included.

Key Dates

Start date
Apr 30, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CDR132L 4.52 mg
    Six times CDR132L 4.52 mg/kg body weight intravenous in single dose.
  • Placebo Comparator: Placebo
    Six times Placebo intravenous in single dose.

Primary Outcome Measure

Left ventricular mass [ Time Frame: 6 months ]

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