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Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478087
Recruitment Status : Terminated (Sponsor terminated due to business reasons)
First Posted : November 23, 2011
Results First Posted : February 11, 2013
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
Asahi Kasei Medical Co., Ltd.

Brief 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).

Condition or disease Intervention/treatment Phase
Cardiomyopathy, Dilated Device: Mysorba Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Immunoadsorption Therapy for Patients With Chronic Non-Ischemic Dilated Cardiomyopathy
Study Start Date : November 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Mysorba(single-arm) Device: Mysorba
Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.

Primary Outcome Measures :
  1. Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment. [ Time Frame: 30 Days Post Treatment ]
  2. Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment. [ Time Frame: 30 days post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is 18 years of age or older.
  2. Subject has provided written informed consent.
  3. Subject has been classified as NYHA Class II or III.
  4. 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.
  5. Subject was diagnosed with non-ischemic dilated cardiomyopathy ≥ 6 months and ≤ 5 years prior to screening visit.
  6. 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
  7. Subject and physician agree to switch subject from ACE inhibitors to ARB for the treatment duration.

Exclusion Criteria:

  1. Subject has been classified as NYHA Class I or IV
  2. Subject is currently pregnant, lactating, or of child-bearing potential and not taking adequate birth control as assessed by Investigator.
  3. Subject is HBV, HCV or HIV positive.
  4. Subject has anemia, defined as hemoglobin < 10.0 g/dL.
  5. 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.
  6. Subject has compromised hepatic function as measured by SGPT (ALT) or SGOT (AST) > three (3) times the upper limit of normal.
  7. Subject had acute myocarditis ≤ 3 months prior to screening visit.
  8. 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.
  9. Subject is on immunosuppressive or immunomodulation therapy: intravenous (IV), intramuscular (IM), or oral.
  10. 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
  11. 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.
  12. Subject has left ventricular noncompaction.
  13. Subject has a left ventricular assist device (LVAD).
  14. Subject has received a heart transplant.
  15. 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)
  16. Subject has undergone cardiac resynchronization therapy ≤ 6 months prior to screening visit.
  17. Subject is unable to take ARB in place of ACE inhibitors.
  18. Subject has a history of stroke ≤ 3 months prior to screening visit.
  19. Subject currently has severe systemic infection requiring treatment with antibiotics.
  20. 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.
  21. Subject has previously undergone immunosuppressive or immunomodulation therapy.
  22. Subject has known hypersensitivity or contraindication to heparin including history of heparin induced thrombocytopenia (HIT).
  23. Subject has history of drug or alcohol abuse or is currently abusing alcohol or drugs.
  24. Subject has active malignancy or tumor, or other non-cardiac medical condition, which causes life expectancy to be less than one year.
  25. 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.
  26. Subject weighs less than 40 kg (88 lbs).
  27. Subject requires major elective procedures (AHA-defined intermediate to high risk surgery) within 6 months post-treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478087

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Asahi Kasei Medical Co., Ltd.
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Principal Investigator: Jeffrey Winters, MD Mayo Clinic
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Responsible Party: Asahi Kasei Medical Co., Ltd. Identifier: NCT01478087    
Other Study ID Numbers: AMA-2011DCM Pilot Study
First Posted: November 23, 2011    Key Record Dates
Results First Posted: February 11, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases