Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Prese… (NCT05953831) | Clinical Trial Compass
WithdrawnPhase 2
Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
Stopped: Transfer of study responsibility and planning
0Started 2024-04
Plain-language 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.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. Provision of signed informed consent prior to any study-specific procedures.
✓. Male or female of non-childbearing potential patients age ≥40 and \<85 years.
✓. 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.
✓. Ejection fraction ≥ 45% (determined by echocardiography at site laboratory)
✓. Increased intraventricular wall thickness (≥11 mm for female and ≥12 mm for male patients by echocardiography at site laboratory)
✓. NT-proBNP \> 300 pg/ml (sinus rhythm); \>900 pg/ml (atrial fibrillation at time of screening/inclusion or documented with the last 6 months)
✓. BMI between 22 kg/m² and 45 kg/m².
Exclusion criteria
✕. Hemoglobin A1C (A1C) ≥10.5%
✕. eGFR \<35 mL/min/1.73m²
✕. Systolic blood pressure (BP) \<90 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.
✕. Systolic BP≥180 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.
✕. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
What they're measuring
1
Left ventricular mass
Timeframe: 6 months
2
Left atrial maximum volume
Timeframe: 6 months
3
Total cardiac extracellular volume
Timeframe: 6 months
4
Left atrial strain
Timeframe: 6 months
5
Maximum left ventricular wall thickness
Timeframe: 6 months
6
Age-adjusted e' velocity
Timeframe: 6 months
7
Global longitudinal strain
Timeframe: 6 months
8
E/e'
Timeframe: 6 months
9
Concentration of N-terminal pro B-type natriuretic peptide