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Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy (REMOD-REVERT)

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ClinicalTrials.gov Identifier: NCT05953831
Recruitment Status : Not yet recruiting
First Posted : July 20, 2023
Last Update Posted : January 8, 2024
Sponsor:
Information provided by (Responsible Party):
Cardior Pharmaceuticals GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Drug: CDR132L Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: IMP to be masked after preparation by unblinded staff.
Primary Purpose: Treatment
Official Title: Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodeling in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: CDR132L 4.52 mg
Six times CDR132L 4.52 mg/kg body weight intravenous in single dose.
 Drug: 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.
Placebo Comparator: Placebo
Six times Placebo intravenous in single dose.
 Drug: Placebo
Placebo to CDR132L


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular mass [ Time Frame: 6 months ]
    Left ventricular mass measured by cardiac magnetic resonance imaging (indexed to the height in meters raised to the power of 2)

  2. Left atrial maximum volume [ Time Frame: 6 months ]
    Left atrial maximum volume (measured by cardiac magnetic resonance imaging in end systole(indexed to the height in meters raised to the power of 2))

  3. Total cardiac extracellular volume [ Time Frame: 6 months ]
    Total cardiac extracellular volume (mL) measured by cardiac magnetic resonance imaging

  4. Left atrial strain [ Time Frame: 6 months ]
    Left atrial strain measured by cardiac magnetic resonance imaging

  5. Maximum left ventricular wall thickness [ Time Frame: 6 months ]
    Maximum left ventricular wall thickness measured by cardiac magnetic resonance imaging

  6. Age-adjusted e' velocity [ Time Frame: 6 months ]
    Age-adjusted e' velocity measured by doppler echocardiography. With e´velocity being the maximal velocity of mitral annular motion (E-wave).

  7. Global longitudinal strain [ Time Frame: 6 months ]
    Global longitudinal strain measured by echocardiography

  8. E/e' [ Time Frame: 6 months ]
    E/e' measured by doppler echocardiography to evaluate the LV filling pressure.

  9. Concentration of N-terminal pro B-type natriuretic peptide [ Time Frame: 6 months ]
    Concentration measured as biomarker from blood samples.

  10. Concentration of high-sensitivity cardiac troponin T [ Time Frame: 6 months ]
    Concentration measured as biomarker from blood samples.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main 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.

Main 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05953831


Contacts
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Contact: Cardior Clinical Team +49511338599 ext 30 clinical@cardior.de

Sponsors and Collaborators
Cardior Pharmaceuticals GmbH
More Information
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Responsible Party: Cardior Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT05953831    
Other Study ID Numbers: CDR132L-P2-06
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: January 8, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cardior Pharmaceuticals GmbH:
HFpEF
Heart failure
Cardiac Hypertrophy
Additional relevant MeSH terms:
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Heart Failure
Cardiomegaly
Hypertrophy
 Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical