Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)
Primary Purpose
Cardiomyopathy, Dilated
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mysorba
Sponsored by
About this trial
This is an interventional treatment trial for Cardiomyopathy, Dilated
Eligibility Criteria
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/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 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.
Sites / Locations
- Mayo Clinic
- Cleveland Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mysorba(single-arm)
Arm Description
Outcomes
Primary Outcome Measures
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01478087
First Posted
November 7, 2011
Last Updated
February 12, 2013
Sponsor
Asahi Kasei Medical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01478087
Brief Title
Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)
Official Title
Pilot Study of Immunoadsorption Therapy for Patients With Chronic Non-Ischemic Dilated Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated due to business reasons
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Medical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Dilated
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mysorba(single-arm)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Mysorba
Intervention Description
Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Primary Outcome Measure Information:
Title
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time Frame
30 Days Post Treatment
Title
Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time Frame
30 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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/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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Winters, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)
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