A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

NCT02915718 | Completed DMC

• 1 other identifier: XCheng
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Dilated Cardiomyopathy

Keywords

dilated cardiomyopathy; immunoadsorption

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (LVEF) at rest

  determined by contrast echocardiography

  six months

Secondary Outcomes (2)

• LVEF at rest

  1 year

• Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)

  6 months

Study Arms (2)

experimental group

EXPERIMENTAL

protein A immunoadsorption for 5 days

Procedure: protein A immunoadsorption

control group

NO INTERVENTION

non intervention

Interventions

protein A immunoadsorption PROCEDURE

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

Also known as: plasma adsorption

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital

Wuhan, Hubei, 430000, China

Location

Related Publications (2)

• 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.

  PMID: 23100283 BACKGROUND

• 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.

  PMID: 22892122 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Tian Xie, master

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, Deputy Director

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 27, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)