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

NCT ID: NCT05953831

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-09-30

Brief Summary

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CDR132L 4.52 mg

Six times CDR132L 4.52 mg/kg body weight intravenous in single dose.

Group Type: EXPERIMENTAL

CDR132L

Intervention Type: 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

Six times Placebo intravenous in single dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to CDR132L

Interventions

CDR132L

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.

Intervention Type: DRUG

Placebo

Placebo to CDR132L

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Provision of signed informed consent prior to any study-specific procedures.

2. Male or female of non-childbearing potential patients age ≥40 and <85 years.

3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrollment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrollment with at least intermittent need for diuretic treatment.

4. Ejection fraction ≥ 45% (determined by echocardiography at site laboratory)

5. Increased intraventricular wall thickness (≥11 mm for female and ≥12 mm for male patients by echocardiography at site laboratory)

6. NT-proBNP > 300 pg/ml (sinus rhythm); >900 pg/ml (atrial fibrillation at time of screening/inclusion or documented with the last 6 months)

7. BMI between 22 kg/m² and 45 kg/m².

Exclusion Criteria

1. Hemoglobin A1C (A1C) ≥10.5%

2. eGFR <35 mL/min/1.73m²

3. Systolic blood pressure (BP) <90 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.

4. Systolic BP≥180 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.

5. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.

6. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardior Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CDR132L-P2-06

Identifier Type: -

Identifier Source: org_study_id