Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)

Cardiomyopathy, Dilated Clinical Trial

Official title:

Pilot Study of Immunoadsorption Therapy for Patients With Chronic Non-Ischemic Dilated Cardiomyopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01478087
• Other study ID #: AMA-2011DCM Pilot Study
• Status: Terminated
• Phase: N/A
• First received: November 7, 2011
• Last updated: February 12, 2013
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Asahi Kasei Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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), ß-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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated

Intervention

Device:
• Mysorba
Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Asahi Kasei Medical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.		30 Days Post Treatment	Yes
Primary	Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.		30 days post-treatment	Yes