Clinical trial NCT02915718: A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
Official title: A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dilated Cardiomyopathy
Keywords: dilated cardiomyopathy
immunoadsorption
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dilated cardiomyopathy (DCM) causes significant morbidity and mortality and is the third most common cause of heart failure and the most frequent reason for heart transplantation. The etiology of dilated cardiomyopathy(DCM) is complex. There is a growing body of literature suggesting that the humoral immune system activation and autoantibodies against myocardial generation play an important role in the progression of DCM. At present immunoadsorption technology has been successfully applied in autoimmune antibody removal treatment of a variety of diseases. And some applications of immunoadsorption(IA) in patients with DCM showed that immunoadsorption(IA) can indeed reduce the autoantibodies, improve symptoms and prognosis, but additional research is needed to identify indications and instruments for the IA treatment of DCM.

Detailed description: 40 patients randomly divided into 2 groups： experimental group and control group

experimental group：

Device: protein A immunoadsorption

protein-A immunoadsorption for 5 days and i.v.(intravenous injection) IgG(Immunoglobulin G）（0.5g/kg Body weight） substitution

control group：

non intervention

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).

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF) at rest
timeFrame: six months
Secondary outcomes:
measure: LVEF at rest
timeFrame: 1 year
measure: Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Tian Xie, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ameling S, Herda LR, Hammer E, Steil L, Teumer A, Trimpert C, Dorr M, Kroemer HK, Klingel K, Kandolf R, Volker U, Felix SB. Myocardial gene expression profiles and cardiodepressant autoantibodies predict response of patients with dilated cardiomyopathy to immunoadsorption therapy. Eur Heart J. 2013 Mar;34(9):666-75. doi: 10.1093/eurheartj/ehs330. Epub 2012 Oct 25.
citation: Dandel M, Wallukat G, Englert A, Lehmkuhl HB, Knosalla C, Hetzer R. Long-term benefits of immunoadsorption in beta(1)-adrenoceptor autoantibody-positive transplant candidates with dilated cardiomyopathy. Eur J Heart Fail. 2012 Dec;14(12):1374-88. doi: 10.1093/eurjhf/hfs123. Epub 2012 Aug 14.