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A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT02915718
Recruitment Status : Unknown
Verified October 2016 by Xiang Cheng, Wuhan Union Hospital, China.
Recruitment status was:  Recruiting
First Posted : September 27, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Xiang Cheng, Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Procedure: protein A immunoadsorption Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
Study Start Date : October 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2018


Arm Intervention/treatment
Experimental: experimental group
protein A immunoadsorption for 5 days
Procedure: protein A immunoadsorption
protein-A immunoadsorption for 5 days and i.v. IgG(0.5g/kg Body weight)substitution
Other Name: plasma adsorption

No Intervention: control group
non intervention



Primary Outcome Measures :
  1. Left ventricular ejection fraction (LVEF) at rest [ Time Frame: six months ]
    determined by contrast echocardiography


Secondary Outcome Measures :
  1. LVEF at rest [ Time Frame: 1 year ]
    determined by contrast echocardiography

  2. Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915718


Contacts
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Contact: Xiang Cheng, doctor +8615972150162 715494934@qq.com

Locations
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China, Hubei
Union Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Tian Xie, master    +8615972150162    715494934@qq.com   
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Principal Investigator: Tian Xie, master Wuhan Union Hospital, China

Publications of Results:
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Responsible Party: Xiang Cheng, Professor, Chief Physician, Deputy Director, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02915718     History of Changes
Other Study ID Numbers: XCheng
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Xiang Cheng, Wuhan Union Hospital, China:
dilated cardiomyopathy
immunoadsorption
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly