Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction (HF-REVERT)

Cardior Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Heart Failure, Left Sided; Myocardial Infarction, Acute

Treatments: Drug: Placebo to CDR132L; Drug: CDR132L

Study type: Interventional

Funder types: Industry

Identifiers

NCT05350969

2023-507569-24-00 (EU Trial (CTIS) Number)

CDR132L-P2-01

2021-006040-27 (EudraCT Number)

Details and patient eligibility

About

This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12.

Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.

Enrollment: 294 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. Male or female patients, aged ≥ 30 to ≤ 80 years at the date of signing informed consent which is defined as the beginning of the Screening Period.
2. Spontaneous acute mycardial infarction (AMI) (type I) based on the universal MI definition with randomization to occur no later than 14 days after index event diagnosis.
3. Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI).
4. Patient with previous MI events in history can be included.
5. Patient with body weight of ≤ 120 kg.
6. N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and < 8000 pg/ml at screening.
7. Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention for this event.

Exclusion Criteria:

1. A woman of childbearing potential (WOCBP).
2. Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
3. Patient with New York Heart Association (NYHA) class IV at screening or randomization.
4. Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
5. Patient has severe valvular heart disease.
6. Patient has systolic BP < 90 mmHg or > 180 mmHg, diastolic BP < 50 mmHg or > 110 mmHg, and/or heart rate < 50 or > 100 beats/minute at screening or randomization.
7. Patient with an estimated glomerular filtration rate < 30 mL/min/1.73 m2 or on dialysis.
8. Patient with hepatic insufficiency classified as Child-Pugh B or C.
9. Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis.
10. Patient has medical history of bleeding disorders or has thrombocytopenia (platelets < 100,000/μL).
11. Patient has poorly controlled diabetes as determined by the Investigator.
12. Patient has a history or presence of any of the following cardiac conditions: known structural cardiac abnormalities beyond HF, family history of long QT syndrome, cardiac syncope, or recurrent, idiopathic syncope.
13. Any clinically significant abnormalities, at the discretion of the Investigator, in rhythm, conduction, or morphology of resting ECG that pose an additional safety risk to patients.
14. Patient with active "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
15. Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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294 participants in 3 patient groups, including a placebo group

CDR132L 5 mg

Experimental group

Description:

CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57

Treatment:

Drug: CDR132L

CDR132L 10 mg

Experimental group

Description:

CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57

Treatment:

Drug: CDR132L

Placebo

Placebo Comparator group

Description:

Placebo intravenous in single dose on Day 1, Day 29 and Day 57

Treatment:

Drug: Placebo to CDR132L