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

This study has been terminated.
(Sponsor terminated due to business reasons)
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Kuraray Medical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01478087
First received: November 7, 2011
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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 Intervention
Cardiomyopathy, Dilated
Device: Mysorba

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Immunoadsorption Therapy for Patients With Chronic Non-Ischemic Dilated Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Asahi Kasei Kuraray Medical Co.,Ltd.:

Primary Outcome Measures:
  • Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment. [ Time Frame: 30 Days Post Treatment ] [ Designated as safety issue: Yes ]
  • Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment. [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mysorba(single-arm) Device: Mysorba
Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478087

Locations
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 Kuraray Medical Co.,Ltd.
Investigators
Principal Investigator: Jeffrey Winters, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Asahi Kasei Kuraray Medical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01478087     History of Changes
Other Study ID Numbers: AMA-2011DCM Pilot Study
Study First Received: November 7, 2011
Results First Received: January 8, 2013
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014