Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction

Phase 2

Completed

• Conditions: Myocardial Infarction, Acute; Heart Failure, Left Sided
• Interventions: Drug: CDR132L; Drug: Placebo to CDR132L

• Registration Number: NCT05350969
• Lead Sponsor: Cardior Pharmaceuticals GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-04-28
• Study Start: 2022-07-07
• Primary Completion: 2024-09-26
• Disposition First Submitted: 2025-01-15
• Study Completion: 2025-03-17
• Disposition First Posted: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDR132L 5 mg	CDR132L	CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57
CDR132L 10 mg	CDR132L	CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57
Placebo	Placebo to CDR132L	Placebo intravenous in single dose on Day 1, Day 29 and Day 57

Primary Outcome Measures

Name	Time	Method
Echocardiography (ECHO)	6 months	Percent change from baseline (screening to occur at least 3 days after MI diagnosis as measured by ECHO \[central laboratory\]) in Left Ventricular End-Systolic Volume (LVESVI) at Month 6.

Trial Locations

Locations (54)

Polsko Amerykanskie Kliniki Serca; 🇵🇱 Kędzierzyn-Koźle, Poland

NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog; 🇵🇱 Sopot, Poland

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands

Slingeland Ziekenhuis; 🇳🇱 Doetinchem, Netherlands

Gelderse Vallei Ziekenhuis; 🇳🇱 Ede, Netherlands

Institut klinicke a experimentalni mediciny; 🇨🇿 Praha, Czechia

Všeobecná fakultní nemocnice v Praze; 🇨🇿 Praha, Czechia

Herzzentrum Dresden Universitätsklinik; 🇩🇪 Dresden, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

St. Marien-Krankenhaus Ahaus; 🇩🇪 Ahaus, Germany

Helios Klinikum Erfurt; 🇩🇪 Erfurt, Germany

"Alexandra" General Hospital of Athens; 🇬🇷 Athens, Greece

Klinikum Leverkusen GmbH; 🇩🇪 Leverkusen, Germany

"Attikon" General University Hospital; 🇬🇷 Athen, Greece

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, Germany

BMKK Pándy Kálmán; 🇭🇺 Gyula, Hungary

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

St. Jansdal Ziekenhuis; 🇳🇱 Lelystad, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Ikazia Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

D & A Research B.V.; 🇳🇱 Sneek, Netherlands

Gelre Ziekenhuizen; 🇳🇱 Zutphen, Netherlands

Krakowski Szpital Specjalistyczny im. Jana Pawla II; 🇵🇱 Kraków, Poland

Wojewódzki Szpital im. Sw. Ojca Pio w Przemyslu; 🇵🇱 Przemyśl, Poland

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital de la Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Spec.Szpital im.dr Sokolowskiego; 🇵🇱 Wałbrzych, Poland

NZOZ SALUS JZ Peruga; 🇵🇱 Łódź, Poland

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Complejo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Spain

South Tees Hospital NHS Foundation Trust; 🇬🇧 Middlesbrough, United Kingdom

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Hospital Universitario San Cecilio; 🇪🇸 Granada, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario de Sabadell; 🇪🇸 Sabadell, Spain

General University Hospital of Patras "Panagia i Voitheia"; 🇬🇷 Patra, Greece

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Semmelweis University; 🇭🇺 Budapest, Hungary

Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch; 🇳🇱 's-Hertogenbosch, Netherlands

Somogy County Kaposi Mór Teaching Hospital; 🇭🇺 Kaposvár, Hungary

BKS Research Ltd.; 🇭🇺 Hatvan, Hungary

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Richmond Pharmacology Limited; 🇬🇧 London, United Kingdom

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Medifarma-98 KFT; 🇭🇺 Nyíregyháza, Hungary

Wycombe Hospital; 🇬🇧 High Wycombe, United Kingdom

Gabinet Internistyczno-Kardiologiczny Jacek Nowak; 🇵🇱 Libiąż, Poland

One wojskowy Szpital Kliniczny w Lublinie; 🇵🇱 Lublin, Poland

Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego; 🇵🇱 Kielce, Poland

Medicome Sp. z o.o.; 🇵🇱 Oświęcim, Poland

Wojewodzki Szpital Zespolony; 🇵🇱 Toruń, Poland

Investigational Site; 🇵🇱 Wrocław, Poland