Status:
TERMINATED
Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)
Lead Sponsor:
Asahi Kasei Medical Co., Ltd.
Conditions:
Cardiomyopathy, Dilated
Eligibility:
All Genders
18+ years
Phase:
NA
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01478087
Start Date
November 1 2011
End Date
June 1 2012
Last Update
February 15 2013
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55901
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195