Dilated Cardiomyopathy (DCM)NCT06922851
Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
A study testing Immunoadsorption in people with Dilated Cardiomyopathy (DCM), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study is a multicenter, dual-arm and randomized controlled clinical trial. Sixty patients with dilated cardiomyopathy and positive β1-adrenergic receptor autoantibodies were selected and randomly divided into an immunoadsorption group (receiving immunoadsorption therapy) and a control group in a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dilated Cardiomyopathy (DCM)
- What is being tested?
- Immunoadsorption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dilated cardiomyopathy
- Presence of anti-β1-adrenergic receptor
- Age 18-75 years
- LVEF ≤ 40% determined by echocardiography (according to assessment of the local investigators)
- NYHA class II-IV
- Symptoms of heart failure ≥ 6 months
Show all 9Show fewer
- Treatment with guideline-directed medical therapy (GDMT) for ≥6 months and stable dose of ACEI/ARB/ARNI/β-blocker/SGLT2i/MRA/sGCa for ≥1 month (excluding diuretics)
- Hemodynamically stable
- Informed consent
Who cannot join
- ICD implantation < 1 month or CRT/D implantation < 6 months
- Heart failure caused by other heart diseases
- End-stage heart failure, inability to discontinue intravenously positive inotropic or vasoactive drugs
- Expected survival < 1 year
- Hemoglobin < 90g/L
- Any disease requiring immunosuppressive drugs
Show all 11Show fewer
- Commodities with other acute or severe illnesses, such as infections, severe hepatic or renal dysfunction, hematological diseases, malignant tumors, cachexia, autoimmune diseases, etc.
- Previous treatment with immunoadsorption therapy or intravenous immunoglobulin therapy
- Contraindications to extracorporeal circulation therapy, such as mental illness or consciousness disorders, shock, severe bleeding or bleeding tendency, coagulation dysfunction, multiple organ failure, etc.
- Pregnancy/lactation
- Any other conditions that the researcher deems may increase the risk to the subject or interfere with the clinical trial and outcome assessment (such as excessive anxiety, alcohol or drug abuse, or cognitive impairment, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tingting Tang, +86-02786726011, nathancx@hust.edu.cn
About this study
Official title: Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)
This study is a multicenter, dual-arm and randomized controlled clinical trial. Sixty patients with dilated cardiomyopathy and positive β1-adrenergic receptor autoantibodies were selected and randomly divided into an immunoadsorption group (receiving immunoadsorption therapy) and a control group in a 1:1 ratio. Changes in cardiac function, morphology and clinical outcomes were followed up and compared.
- Conditions
- Dilated Cardiomyopathy (DCM)
- Being tested
- 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.
ImmunoadsorptionProcedure or surgery
Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA
| Study group | Role | What they receive |
|---|---|---|
| Immuoadsorption group | Experimental | receiving immunoadsorption therapy Receives: Procedure: Immunoadsorption |
| Control group | No intervention | not receiving immunoadsorption therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LVEF from baseline to 6 months determined by echocardiography
Measured: From enrollment to follow-up at 6 months
Secondary outcomes (5)
LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months
Measured: From enrollment to follow-up at 24 months
LVEDD and LVESD as determined by echocardiography at baseline and after 3, 6, 12 and 24 months
Measured: From enrollment to follow-up at 24 months
NYHA classification at baseline and after 3, 6, 12 and 24 months
Measured: From enrollment to follow-up at 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline and after 3, 6, 12 and 24 months
KCCQ score is scaled from 0 to 100 and higher scores mean better health status.
Measured: From enrollment to follow-up at 24 months
NT-proBNP at baseline and after 3, 6, 12 and 24 months
Measured: From enrollment to follow-up at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start4 Jun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated Cardiomyopathy (DCM)Studies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- Xiang Cheng, M.D., Ph.D., Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922851
- Sponsor's protocol ID
- PRIA-DCM
- Status last verified
- May 2025
- First submitted
- 3 Apr 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)
- ClinicalTrials.gov ID
- NCT06922851
- Acronym / sponsor ID
- PRIA-DCM
- Conditions
- Dilated Cardiomyopathy (DCM)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 4 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Apr 2025 (actual)
- 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.
This study is a multicenter, dual-arm and randomized controlled clinical trial. Sixty patients with dilated cardiomyopathy and positive β1-adrenergic receptor autoantibodies were selected and randomly divided into an immunoadsorption group (receiving immunoadsorption therapy) and a control group in a 1:1 ratio. Changes in cardiac function, morphology and clinical outcomes were followed up and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immuoadsorption group | Experimental | Procedure: Immunoadsorptionreceiving immunoadsorption therapy |
| Control group | No intervention | –not receiving immunoadsorption therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Dilated cardiomyopathy
- Presence of anti-β1-adrenergic receptor
- Age 18-75 years
- LVEF ≤ 40% determined by echocardiography (according to assessment of the local investigators)
- NYHA class II-IV
Key exclusion criteria (11 listed)
- ICD implantation < 1 month or CRT/D implantation < 6 months
- Heart failure caused by other heart diseases
- End-stage heart failure, inability to discontinue intravenously positive inotropic or vasoactive drugs
- Expected survival < 1 year
- Hemoglobin < 90g/L
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 |
|---|---|---|
| ImmunoadsorptionImmunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA | Procedure or surgery | Immuoadsorption group |
Primary outcome
Change in LVEF from baseline to 6 months determined by echocardiography
Time frame: From enrollment to follow-up at 6 months
5 secondary outcomes
LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months
Time frame: From enrollment to follow-up at 24 months
LVEDD and LVESD as determined by echocardiography at baseline and after 3, 6, 12 and 24 months
Time frame: From enrollment to follow-up at 24 months
NYHA classification at baseline and after 3, 6, 12 and 24 months
Time frame: From enrollment to follow-up at 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline and after 3, 6, 12 and 24 months
Time frame: From enrollment to follow-up at 24 months
NT-proBNP at baseline and after 3, 6, 12 and 24 months
Time frame: From enrollment to follow-up at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Dilated Cardiomyopathy (DCM)
RecruitingPhase 3
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
Not yet recruitingObservational study
BAG3-DCM Natural History Study
Dilated Cardiomyopathy (DCM), Cardiovascular Diseases
RecruitingPhase 1
A Phase 1 AAV Gene Therapy Trial Evaluating Safety and Preliminary Efficacy of RP-A701 in Subjects With BAG3 Dilated Cardiomyopathy
Dilated Cardiomyopathy (DCM)
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.
Xiang Cheng, M.D., Ph.D. 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 Immunoadsorption in people with Dilated Cardiomyopathy (DCM), 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang Cheng, Professor (+86-18107265338, nathancx@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LVEF from baseline to 6 months determined by echocardiography (time frame: From enrollment to follow-up at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.