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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Medical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 7, 2011
First Posted Date  ICMJE November 23, 2011
Results First Submitted Date  ICMJE January 8, 2013
Results First Posted Date  ICMJE February 11, 2013
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE November 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01478087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)
Official Title  ICMJE Pilot Study of Immunoadsorption Therapy for Patients With Chronic Non-Ischemic Dilated Cardiomyopathy
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiomyopathy, Dilated
Intervention  ICMJE Device: Mysorba
Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Study Arms  ICMJE Mysorba(single-arm)
Intervention: Device: Mysorba
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 5, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2011)
20
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01478087
Other Study ID Numbers  ICMJE AMA-2011DCM Pilot Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asahi Kasei Medical Co., Ltd.
Study Sponsor  ICMJE Asahi Kasei Medical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Winters, MD Mayo Clinic
PRS Account Asahi Kasei Medical Co., Ltd.
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP