A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

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Brief Title

A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Official Title

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

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
    


Study Type

Interventional


Primary Outcome

Left ventricular ejection fraction (LVEF) at rest

Secondary Outcome

 LVEF at rest

Condition

Dilated Cardiomyopathy

Intervention

protein A immunoadsorption

Study Arms / Comparison Groups

 experimental group
Description:  protein A immunoadsorption for 5 days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

40

Start Date

October 2016

Completion Date

February 2018

Primary Completion Date

February 2017

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).
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Tian Xie, master, +8615972150162, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02915718

Organization ID

XCheng


Responsible Party

Principal Investigator

Study Sponsor

Wuhan Union Hospital, China


Study Sponsor

Tian Xie, master, Principal Investigator, Wuhan Union Hospital, China


Verification Date

October 2016