Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT02915718
Eligibility Criteria:
Inclusion Criteria:
* Dilated cardiomyopathy
* LVEF \<= 40% determined by contrast echocardiography
* NYHA(New York Heart Association) class II - IV
* Age 18-70
* Disease duration: symptomatic heart failure ≥ 6 months prior to screening date
* Treatment with Angiotensin-Converting Enzyme inhibitors(ACEI) 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 and at stable doses for at least 2 months prior to screening date.
* β1 adrenergic receptor antibody positive
* The patient's informed consent
Exclusion Criteria:
* NYHA class IV patients who are bed-ridden and dependent upon parenteral medication
* Cardiac insufficiency resulting from another basic disease (e.g. coronary artery disease, ≥50% stenosis of major vessel as ascertained by coronary angiography performed more recent than three years before screening date, hypertensive heart disease, or valvular defects \>second degree
* History of myocardial infarction
* Acute myocarditis according to Dallas criteria
* Endocrine disorder excluding insulin-dependent diabetes mellitus
* Implanted cardiac defibrillator (ICD) \<1 month before screening date
* Cardiac resynchronization therapy (CRT) \<6 months before screening date
* I.v. medication with inotropic drugs, vasodilators or repeated (\>1/day) i.v. administration of diuretics.
* Active infectious disease, or signs of ongoing infection with C-reactive protein(CRP) \>10mmol/L
* Impaired renal function (serum creatinine \>220 µmol/L)
* Any disease requiring immunosuppressive drugs
* Anaemia (haemoglobin below 90 g/L) due to other causes than congestive heart failure(CHF)
* Pregnancy or lactation, or childbearing potential without appropriate contraception
* Alcohol or drug abuse
* Presence of a malignant tumour, or remission of malignancy \< 5 years
* Refusal of the patient to provide consent
* Suspected poor capability to follow instructions and cooperate
* Another life-threatening disease with poor prognosis (survival less than 2 years)
* Participation in any other clinical study within less than 30 days prior to screening date
* Previous treatments with IA or immunoglobulin
* Contraindications for application of the echocardiography contrast agent used (in accordance to the product specification).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02915718
Study Brief:
Protocol Section:
NCT02915718