Cardiomyopathy, DilatedNCT01478087
Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)
A study testing Mysorba in people with Cardiomyopathy, Dilated, run by Asahi Kasei Medical Co., Ltd. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the clinical safety and feasibility of Mysorba in patients with chronic non-ischemic dilated cardiomyopathy (DCM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Dilated
- What is being tested?
- Mysorba
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older.
- Subject has provided written informed consent.
- Subject has been classified as NYHA Class II or III.
- Subject has been diagnosed with chronic non-ischemic dilated cardiomyopathy, defined as left ventricular ejection fraction (LVEF) < 40% and left ventricular end diastolic dimensions (LVEDd) > 55 millimeters (mm) or LVEDd/BSA > 3.0 cm/m2.
- Subject was diagnosed with non-ischemic dilated cardiomyopathy ≥ 6 months and ≤ 5 years prior to screening visit.
- Subject is on stable optimal medical therapy, consisting of ACE inhibitor (or ARB), β-blocker, and diuretic, for heart failure for at least 3 months
- Subject and physician agree to switch subject from ACE inhibitors to ARB for the treatment duration.
Who cannot join
- Subject has been classified as NYHA Class I or IV
- Subject is currently pregnant, lactating, or of child-bearing potential and not taking adequate birth control as assessed by Investigator.
- Subject is HBV, HCV or HIV positive.
- Subject has anemia, defined as hemoglobin < 10.0 g/dL.
- Subject has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL or eGFR <30 mL/min or is currently on dialysis.
- Subject has compromised hepatic function as measured by SGPT (ALT) or SGOT (AST) > three (3) times the upper limit of normal.
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- Subject had acute myocarditis ≤ 3 months prior to screening visit.
- Subject has a history of diameter stenosis >70% of at least one major coronary artery, as determined by angiography or CTA obtained within the previous 5 years.
- Subject is on immunosuppressive or immunomodulation therapy: intravenous (IV), intramuscular (IM), or oral.
- Subject has a history of the following pre-existing heart disease:
- myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG)
- valvular heart disease requiring repair, replacement, or balloon valvuloplasty
- hypertrophic/restrictive cardiomyopathy or constrictive pericarditis
- Subject is currently participating in, or ≤ 6 months prior to screening visit has participated in, an investigational study of a new drug, biologic, or device.
- Subject has left ventricular noncompaction.
- Subject has a left ventricular assist device (LVAD).
- Subject has received a heart transplant.
- Subject has DCM due to any of the following:
- amyloidosis
- sarcoidosis
- connective tissue disease
- peripartum cardiomyopathy
- alcoholism
- endocrine dysfunction as the primary cause of DCM
- prior illicit drug use which the investigator feels as likely cause for the cardiomyopathy
- hereditary and familial conditions (such as genetic dilated cardiomyopathy, familial storage disease, Heredofamilial neurologic and neuromuscular diseases)
- Subject has undergone cardiac resynchronization therapy ≤ 6 months prior to screening visit.
- Subject is unable to take ARB in place of ACE inhibitors.
- Subject has a history of stroke ≤ 3 months prior to screening visit.
- Subject currently has severe systemic infection requiring treatment with antibiotics.
- Subject currently has hemodynamic instability defined as systolic blood pressure < 90 mm Hg without afterload reduction, or cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump.
- Subject has previously undergone immunosuppressive or immunomodulation therapy.
- Subject has known hypersensitivity or contraindication to heparin including history of heparin induced thrombocytopenia (HIT).
- Subject has history of drug or alcohol abuse or is currently abusing alcohol or drugs.
- Subject has active malignancy or tumor, or other non-cardiac medical condition, which causes life expectancy to be less than one year.
- History of neutropenia (WBC < 3,000/mm3), coagulopathy, or thrombocytopenia (platelet count < 100,000/μL) that has not resolved or has required treatment in the past 6 months.
- Subject weighs less than 40 kg (88 lbs).
- Subject requires major elective procedures (AHA-defined intermediate to high risk surgery) within 6 months post-treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Mayo Clinic
Rochester, Minnesota, 55901
About this study
Official title: Pilot Study of Immunoadsorption Therapy for Patients With Chronic Non-Ischemic Dilated Cardiomyopathy
The purpose of this study is to evaluate the clinical safety and feasibility of Mysorba in patients with chronic non-ischemic dilated cardiomyopathy (DCM).
- Conditions
- Cardiomyopathy, Dilated
- Being tested
- Mysorba
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MysorbaDevice
Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mysorba(single-arm) | Other | Not described Receives: Device: Mysorba |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Measured: 30 Days Post Treatment
Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Measured: 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Sponsor terminated due to business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiomyopathy, DilatedStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Winters, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478087
- Sponsor's protocol ID
- AMA-2011DCM Pilot Study
- Status last verified
- Feb 2013
- First submitted
- 7 Nov 2011
- Last updated
- 15 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Immunoadsorption Therapy for Patients With Chronic Non-Ischemic Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01478087
- Acronym / sponsor ID
- AMA-2011DCM Pilot Study
- Conditions
- Cardiomyopathy, Dilated
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated due to business reasons
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Asahi Kasei Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Posted 11 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical safety and feasibility of Mysorba in patients with chronic non-ischemic dilated cardiomyopathy (DCM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mysorba(single-arm) | Other | Device: Mysorba |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 18 years of age or older.
- Subject has provided written informed consent.
- Subject has been classified as NYHA Class II or III.
- Subject has been diagnosed with chronic non-ischemic dilated cardiomyopathy, defined as left ventricular ejection fraction (LVEF) < 40% and left ventricular end diastolic dimensions (LVEDd) > 55 millimeters (mm) or LVEDd/BSA > 3.0 cm/m2.
- Subject was diagnosed with non-ischemic dilated cardiomyopathy ≥ 6 months and ≤ 5 years prior to screening visit.
Key exclusion criteria (38 listed)
- Subject has been classified as NYHA Class I or IV
- Subject is currently pregnant, lactating, or of child-bearing potential and not taking adequate birth control as assessed by Investigator.
- Subject is HBV, HCV or HIV positive.
- Subject has anemia, defined as hemoglobin < 10.0 g/dL.
- Subject has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL or eGFR <30 mL/min or is currently on dialysis.
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 |
|---|---|---|
| MysorbaSubjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks. | Device | Mysorba(single-arm) |
Primary outcome
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time frame: 30 Days Post Treatment
Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time frame: 30 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Dilated Cardiomyopathy
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.
Jeffrey Winters, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mysorba in people with Cardiomyopathy, Dilated, run by Asahi Kasei Medical Co., Ltd. at 2 sites in United States.
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 7 inclusion and 38 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: stopped early, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment. (time frame: 30 Days Post Treatment). The study lists 2 primary outcomes in all. 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 15 Feb 2013.