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Phase 2 Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (≤45%) After Myocardial Infarction (HF-REVERT)
EU CTIS ID: 2023-507569-24-00
What this study is testing
To assess the efficacy of 2 dose levels (5 and 10 mg/kg) of CDR132L compared with placebo administered in 3 single IV doses given 28-days apart in patients with reduced LVEF ≤ 45% after MI (STEMI or NSTEMI) as add-on therapy to SoC treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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.
- Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI).
- Patient with previous MI events in history can be included.
- Patient with body weight of ≤ 120 kg.
- N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and < 8000 pg/ml at screening.
You likely can't join if
- A woman of childbearing potential (WOCBP).
- Patient has medical history of bleeding disorders or has thrombocytopenia (platelets < 100,000/μL).
- Patient has poorly controlled diabetes as determined by the Investigator.
- 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.
- 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.
- Patient with active and clinical relevant "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
See the full eligibility criteria
- 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.
- 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.
- Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI).
- Patient with previous MI events in history can be included.
- Patient with body weight of ≤ 120 kg.
- N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and < 8000 pg/ml at screening.
- Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention for this event.
- A woman of childbearing potential (WOCBP).
- Patient has medical history of bleeding disorders or has thrombocytopenia (platelets < 100,000/μL).
- Patient has poorly controlled diabetes as determined by the Investigator.
- 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.
- 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.
- Patient with active and clinical relevant "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
- Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.
- Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
- Patient with New York Heart Association (NYHA) class IV at screening or randomization.
- Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
- Patient has severe valvular heart disease.
- 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.
- Patient with an estimated glomerular filtration rate < 30 mL/min/1.73 m2 or on dialysis.
- Patient with hepatic insufficiency classified as Child-Pugh B or C.
- Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.