NCT01478087TerminatedNot Applicable
Pilot Study of Immunoadsorption Therapy for Patients With Chronic Non-Ischemic Dilated Cardiomyopathy
Asahi Kasei Medical Co., Ltd.4 sites in 1 country2 target enrollmentStarted: November 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 2
- Locations
- 4
- Primary Endpoint
- Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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.
Outcomes
Primary Outcomes
Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time Frame: 30 days post-treatment
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time Frame: 30 Days Post Treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
Loading locations...
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