Heart Failure, Dilated Cardiomyopathy MedDRA version: 14.1 Level: LLT Classification code 10056419 Term: Dilated cardiomyopathy System Organ Class: 100000004849
Conditions
Interventions
Product Name: COR-1
Product Code: COR-1
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: COR-1
Current Sponsor code: COR-1
Concentration unit: mg milligram(s)
Concentration
Sponsors
Corimmun GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosed heart failure due to dilated cardiomyopathy - presence of anti-ß1-adrenoreceptor autoantibodies in patients` blood samples - LVEF 1 year and =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Ischemic heart disease characterised by = 50% coronary artery stenosis and/or history of myocardial infarction as determined by coronary angiography - Third or higher degree valvular defect - Clinically relevant disorder of the immune system (as determined by anamnesis) - History of severe allergies, increased risk for anaphylactic shock (as determined by anamnesis e.g. bronchial asthma) - Any disease requiring immunosuppressive drugs, except = 5 mg/day prednisone equivalent dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether intravenous COR-1 administration every 4 weeks in addition to standard therapy enhances cardiac function at rest in patients with heart failure due to DCM, compared to standard therapy alone after 6 months.;Secondary Objective: Secondary objectives aim to determine the efficacy and safety of COR-1 in DCM patients and characterise patient-specific factors that may predict COR-1 treatment success.;Primary end point(s): The primary efficacy measure of COR-1 treatment is to assess the change in left ventricular ejection fraction (LVEF) from baseline to 6 months by biplane echocardiography. ;Timepoint(s) of evaluation of this end point: baseline to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary / Exploratory Efficacy Endpoints -Change in LVEF from baseline to 9 months by biplane echocardiography -Change in transmitral flow velocity time integral and tissue Doppler mitral annular velocity from baseline to 6 months by echocardiography -Change in NT-Pro-BNP values from baseline to 6 months -Investigating whether COR-1 treatment attenuates cardiac morbidity by measuring the extent of heart failure by New York Heart Association (NYHA) classification throughout the study -Occurrence of major adverse cardiac events (MACE) -Monitoring any change in exercise capacity (six-minute walk test) from baseline to 6 and 9 months -Monitoring quality of life at baseline and 6 months -Monitoring Holter ECG parameters from baseline to 6 months -Monitoring disease progression and survival by assessing all-cause death, cardiac resuscitation, emergency hospitalisation for heart failure, clinical deterioration and need for cardiac surgery to improve myocardial pump function (e.g. transplantation, mechanical assist, myoplasty, bi-ventricular pacing) -Comparison of COR-1 treatment success from baseline to 6 and 9 months obetween patients receiving beta-blockers and those who do not o based on patients’ age o based on patients’ disease duration and symptom duration;Timepoint(s) of evaluation of this end point: summarised at 6 and 9 months | — |
Countries
Germany
Contacts
Public ContactClinical Registry group
Janssen-Cilag International N.V.
Outcome results
None listed