- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478087
Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)
February 12, 2013 updated by: Asahi Kasei Medical Co., Ltd.
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55901
- Mayo Clinic
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Mysorba(single-arm)
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Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time Frame: 30 Days Post Treatment
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30 Days Post Treatment
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Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time Frame: 30 days post-treatment
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30 days post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey Winters, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
November 7, 2011
First Submitted That Met QC Criteria
November 22, 2011
First Posted (Estimate)
November 23, 2011
Study Record Updates
Last Update Posted (Estimate)
February 15, 2013
Last Update Submitted That Met QC Criteria
February 12, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMA-2011DCM Pilot Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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