Clinical trial NCT05953831: Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: HFpEF
Heart failure
Cardiac Hypertrophy
Lead sponsor: Cardior Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Left ventricular mass
timeFrame: 6 months
measure: Left atrial maximum volume
timeFrame: 6 months
measure: Total cardiac extracellular volume
timeFrame: 6 months
measure: Left atrial strain
timeFrame: 6 months
measure: Maximum left ventricular wall thickness
timeFrame: 6 months
measure: Age-adjusted e' velocity
timeFrame: 6 months
measure: Global longitudinal strain
timeFrame: 6 months
measure: E/e'
timeFrame: 6 months
measure: Concentration of N-terminal pro B-type natriuretic peptide
timeFrame: 6 months
measure: Concentration of high-sensitivity cardiac troponin T
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: