Cardiomyopathy, Dilated
Conditions
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).
Interventions
DEVICEMysorba
Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Sponsors
Asahi Kasei Medical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment. | 30 Days Post Treatment |
| Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment. | 30 days post-treatment |
Countries
United States
Participant flow
Recruitment details
First site open to enrollment : November 3, 2011 Study terminated: March 22, 2012
Pre-assignment details
Three (3) subjects enrolled, 2 completed treatment through six-month follow up. One (1) subject terminated participation prior to treatment due to sponsor stopping the study.
Participants by arm
| Arm | Count |
|---|---|
| IA Treatment The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | due to sponsor closing study | 1 |
Baseline characteristics
| Characteristic | IA Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age Continuous | 54.0 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time frame: 30 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IA Treatment | Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment. | 0 percentage of device related SAE |
Primary
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Time frame: 30 Days Post Treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IA Treatment | Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment. | 0 percentage of procedure related SAE |