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

Phase 2

Withdrawn

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Drug: Placebo; Drug: CDR132L

• Registration Number: NCT05953831
• Lead Sponsor: Cardior Pharmaceuticals GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-20
• Study Start: 2024-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Six times Placebo intravenous in single dose.
CDR132L 4.52 mg	CDR132L	Six times CDR132L 4.52 mg/kg body weight intravenous in single dose.

Primary Outcome Measures

Name	Time	Method
Left atrial maximum volume	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))
Total cardiac extracellular volume	6 months	Total cardiac extracellular volume (mL) measured by cardiac magnetic resonance imaging
Left atrial strain	6 months	Left atrial strain measured by cardiac magnetic resonance imaging
Concentration of N-terminal pro B-type natriuretic peptide	6 months	Concentration measured as biomarker from blood samples.
Maximum left ventricular wall thickness	6 months	Maximum left ventricular wall thickness measured by cardiac magnetic resonance imaging
Age-adjusted e' velocity	6 months	Age-adjusted e' velocity measured by doppler echocardiography. With e´velocity being the maximal velocity of mitral annular motion (E-wave).
Concentration of high-sensitivity cardiac troponin T	6 months	Concentration measured as biomarker from blood samples.
Left ventricular mass	6 months	Left ventricular mass measured by cardiac magnetic resonance imaging (indexed to the height in meters raised to the power of 2)
Global longitudinal strain	6 months	Global longitudinal strain measured by echocardiography
E/e'	6 months	E/e' measured by doppler echocardiography to evaluate the LV filling pressure.