Clinical trial NCT01478087: 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
Overall status: TERMINATED
Phase: NA
Conditions: Cardiomyopathy, Dilated
Lead sponsor: Asahi Kasei Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
timeFrame: 30 Days Post Treatment
measure: Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
timeFrame: 30 days post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Mayo Clinic
name: Jeffrey Winters, MD
role: PRINCIPAL_INVESTIGATOR
References: