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

Cardior Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Drug: Placebo; Drug: CDR132L

Study type: Interventional

Funder types: Industry

Identifiers

NCT05953831

CDR132L-P2-06

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups, including a placebo group

CDR132L 4.52 mg

Experimental group

Description:

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

Treatment:

Drug: CDR132L

Placebo

Placebo Comparator group

Description:

Six times Placebo intravenous in single dose.

Treatment:

Drug: Placebo