COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide in Heart Failure: a Phase II, Multicentre, Randomised, Double-blind and Placebo-controlled Study With Parallel Groups

Phase 2

Recruiting

• Conditions: MedDRA - 10007541 - Cardiac disordersMedDRA - 10056419 - Dilated cardiomyopathy; I42.0; Dilated cardiomyopathy

• Registration Number: DRKS00003149
• Lead Sponsor: Corimmun GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

•Signed written informed consent
•Heart failure due to dilated cardiomyopathy and detection of anti-ß1-AR autoantibodies
•LVEF less than or equal to 45% as determined by biplane echocardiography
•NYHA class II - III
•symptomatic heart failure >1 year and <8 years prior to screening date
•Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers and aldosterone antagonists (the latter at the discretion of the attending physician) for at least 6 months (with the exception of lack of tolerability of any of these drugs) and at stable doses for at least 2 months prior to screening

Exclusion Criteria

1) Sex and reproductive Status:
•WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product.
•Women who are pregnant or breastfeeding
•Women with a positive pregnancy test on enrolment or prior to investigational product administration.

2) Target disease exceptions
•ischemic heart disease characterised by = 50% coronary artery stenosis as determined by coronary angiography
•history of myocardial infarction
•third or higher degree valvular defect

3) Medical History and concurrent disease
•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)
•Clinically relevant endocrine disorder (patients with insulin-dependent diabetes mellitus may be included if HbA1c is < 8.5 % and no severe nerve damage or ulceration of lower extremities are observed upon physical examination)
•Thyroid disorder with abnormal T3/T4 values, TSH values may deviate (patients may be rescreened if T3/T4 values have normalised 2 months after initial screening)
•Implanted cardiac defibrillator (ICD) <1 month before screening
•Cardiac resynchronisation therapy (CRT) <6 months before screening
•Active infectious disease, or signs of ongoing infection with a serum level of C-reactive protein (CRP) >100 mg/dl
•Impaired renal function (glomerular filtration rate (GFR) <30 ml/min/1.73m² according to Modification of Diet in Renal Disease (MDRD) formula)
•Anaemia (haemoglobin below 90 g/L)
•Presence of a malignant tumour, or remission of malignancy < 5 years if life expectancy is less than 2 years
•A second life-threatening disease with poor prognosis (survival less than 2 years)
•Any severe liver dysfunction (transaminase levels increased to more than 5-fold of upper normal range limit or cholinesterase levels decreased to less than one third of normal range limit)
•Congenital neuromuscular disorder or myasthenia gravis (as determined by anamnesis)

4) Prohibited Treatments and/or therapies
• I.v. medication with inotropic drugs, vasodilators or repeated i.v. administration of diuretics (>1/day).
•Any disease requiring immunosuppressive drugs, except = 5 mg/day prednisone-equivalent dose
•Participation in any other interventional study within less than 30 days prior to screening date

5) Other Exclusion criteria
•Inability to provide informed consent
•Suspected poor capability to follow instructions and cooperate
•Prisoners or subjects who are involuntarily incarcerated
•Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
•Ongoing drug or alcohol abuse

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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.