A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
Primary Purpose
Dilated Cardiomyopathy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
protein A immunoadsorption
Sponsored by
About this trial
This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring dilated cardiomyopathy, immunoadsorption
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).
Sites / Locations
- Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control group
Arm Description
protein A immunoadsorption for 5 days
non intervention
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction (LVEF) at rest
determined by contrast echocardiography
Secondary Outcome Measures
LVEF at rest
determined by contrast echocardiography
Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)
Full Information
NCT ID
NCT02915718
First Posted
September 20, 2016
Last Updated
October 8, 2016
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT02915718
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
Keywords
dilated cardiomyopathy, immunoadsorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
protein A immunoadsorption for 5 days
Arm Title
control group
Arm Type
No Intervention
Arm Description
non intervention
Intervention Type
Procedure
Intervention Name(s)
protein A immunoadsorption
Other Intervention Name(s)
plasma adsorption
Intervention Description
protein-A immunoadsorption for 5 days and i.v. IgG(0.5g/kg Body weight)substitution
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF) at rest
Description
determined by contrast echocardiography
Time Frame
six months
Secondary Outcome Measure Information:
Title
LVEF at rest
Description
determined by contrast echocardiography
Time Frame
1 year
Title
Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Cheng, doctor
Phone
+8615972150162
Email
715494934@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tian Xie, master
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tian Xie, master
Phone
+8615972150162
Email
715494934@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
23100283
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.
Results Reference
result
PubMed Identifier
22892122
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.
Results Reference
result
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A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
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