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

Stopped early · Not applicable

Conditions studied: Cardiomyopathy, Dilated

In brief

The purpose of this study is to evaluate the clinical safety and feasibility of Mysorba in patients with chronic non-ischemic dilated cardiomyopathy (DCM).

Key facts

Study ID

NCT01478087

Run by

Asahi Kasei Medical Co., Ltd.

People needed

2

Starts

2011-11-01

Expected to finish

2012-06-01

Last updated by the study team

2013-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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