A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

Official title:

A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02915718
• Other study ID #: XCheng
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2016
• Last updated: October 8, 2016
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: October 2016
• Source: Wuhan Union Hospital, China
• Contact: Xiang Cheng, doctor
• Phone: +8615972150162
• Email: 715494934[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

• ß1 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Procedure:
• protein A immunoadsorption
protein-A immunoadsorption for 5 days and i.v. IgG(0.5g/kg Body weight)substitution

Locations

Country	Name	City	State
China	Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (2)

Ameling S, Herda LR, Hammer E, Steil L, Teumer A, Trimpert C, Dörr M, Kroemer HK, Klingel K, Kandolf R, Völker U, Felix SB. Myocardial gene expression profiles and cardiodepressant autoantibodies predict response of patients with dilated cardiomyopathy to — View Citation

Dandel M, Wallukat G, Englert A, Lehmkuhl HB, Knosalla C, Hetzer R. Long-term benefits of immunoadsorption in ß(1)-adrenoceptor autoantibody-positive transplant candidates with dilated cardiomyopathy. Eur J Heart Fail. 2012 Dec;14(12):1374-88. doi: 10.109 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF) at rest	determined by contrast echocardiography	six months	No
Secondary	LVEF at rest	determined by contrast echocardiography	1 year	No
Secondary	Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)		6 months	No