Reduced Left Ventricular Ejection Fraction
Conditions
Interventions
-Group 1 receives 5 mg/kg of study drug.
-Group 2 receives 10 mg/kg of the study drug.
-Group 3 gets the placebo.
Sponsors
IQVIA Biotech
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female of non-childbearing potential patients, aged >= 30 to = 125 pg/ml and
Exclusion criteria
Exclusion criteria: 1.A woman of childbearing potential (WOCBP) as defined in Appendix 5. 2.Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy. 3.Patient with history of decompensated HF or a history of LVEF 180 mmHg, diastolic BP 110 mmHg, and/or heart rate 100 beats/minute at screening or randomization. 8.Patient with an estimated glomerular filtration rate = 2 × the ULN and ALT levels of >= 3 × ULN. 12.Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis. 13.Patient has medical history of bleeding disorders or has thrombocytopenia (platelets < 100,000/µL). 14.Patient has poorly controlled diabetes as determined by the Investigator. 15.Patient is currently on treatment for epilepsy. 16.Patient has a current or relevant history of physical or psychiatric illness that is/are not stable or may require a change in treatment, use of prohibited therapies during the study, or cause the patient to be unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the study drug or study procedures. 17.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. 18.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. This will include patients with any of the following (at Screening Visit or Day -1): a)Clinically significant PR (PQ) interval prolongation. b)Intermittent second- or third degree atrioventricular block. c)Sustained cardiac arrhythmia including (but not limited to) supraventricular tachycardia, any symptomatic arrhythmia with the exception of isolated extra systoles. 19.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. 20.Patient has other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the result of the study or the patient's ability to participate in the study. 21.Patient has received an investigational product or treated with an investigational device within 90 days prior to first study drug administration. 22.Patient has known or suspected intolerance or hypersensitivity to the study drug, any closely related compound, or any of the stated ingredients. 23.P
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as percent (%) change from baseline LVESVI at Month 6 compared with baseline (after reperfusion, before treatment start) on top of SoC as measured by ECHO (central laboratory). The comparison will be done for the 10 mg/kg dose group versus placebo, followed by 5 mg/kg versus placebo within a hierarchical two-step test procedure. The aim is to show superiority of the 10 mg/kg dose group (µT10) and the 5 mg/kg dose group (µT5) in comparison to placebo (µP) within a hierarchical test procedure with 2 steps: Step 1 • H01: µT10 µP If Step 1 is successful, then proceed to Step 2. CONFIDENTIAL Protocol CDR132L-P2-01 - original protocol 56 If Step 1 is not successful, then do not proceed to Step 2. Step 2 • H02: µT5 µP To show superiority, the effect of the 10 mg dose group on the percent change in LVESVI must be larger (i.e., higher decrease) than the effect within the placebo group. The percent change from baseline in LVESVI will be analyzed using ANCOVA, with placebo acting as the reference. The model will include treatment as a fixed effect and baseline LVESVI as a covariate. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline in continuous secondary endpoints will also be analyzed using ANCOVA, with placebo acting as the reference. The model will include treatment as a fixed effect and baseline value as a covariate. | — |
Countries
Netherlands
Outcome results
None listed