Dilated CardiomyopathyNCT02915718
A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
A study testing protein A immunoadsorption in people with Dilated Cardiomyopathy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- protein A immunoadsorption
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
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.
Read the 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
- Conditions
- Dilated Cardiomyopathy
- Being tested
- protein A immunoadsorption
- Keywords
- dilated cardiomyopathy, immunoadsorption
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein A immunoadsorptionProcedure or surgery
Also called plasma adsorption
protein-A immunoadsorption for 5 days and i.v. IgG（0.5g/kg Body weight）substitution
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | protein A immunoadsorption for 5 days Receives: Procedure: protein A immunoadsorption |
| control group | No intervention | non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF) at rest
determined by contrast echocardiography
Measured: six months
Secondary outcomes (2)
LVEF at rest
determined by contrast echocardiography
Measured: 1 year
Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2022
- Study completionFeb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Cheng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Tian Xie, master, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915718
- Sponsor's protocol ID
- XCheng
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2016
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 23100283Dandel 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.
PubMed 22892122
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02915718
- Acronym / sponsor ID
- XCheng
- Conditions
- Dilated Cardiomyopathy
- Keywords
- dilated cardiomyopathy, immunoadsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Feb 2022 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: protein A immunoadsorptionprotein A immunoadsorption for 5 days |
| control group | No intervention | –non intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein A immunoadsorptionAlso: plasma adsorptionprotein-A immunoadsorption for 5 days and i.v. IgG（0.5g/kg Body weight）substitution | Procedure or surgery | experimental group |
Primary outcome
Left ventricular ejection fraction (LVEF) at rest
Time frame: six months
determined by contrast echocardiography
2 secondary outcomes
LVEF at rest
Time frame: 1 year
Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Results publication: PubMed 23100283Ameling 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 publication: PubMed 22892122Dandel 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tian Xie, master principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein A immunoadsorption in people with Dilated Cardiomyopathy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) at rest (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02915718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.