NCT01478087

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 11, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

November 7, 2011

Results QC Date

January 8, 2013

Last Update Submit

February 12, 2013

Conditions

Cardiomyopathy, Dilated

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Mysorba(single-arm)

OTHER
Device: Mysorba

Interventions

MysorbaDEVICE

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

Mysorba(single-arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Jeffrey Lawrence Winters, MD
Organization
Mayo Clinic
winters.jeffrey@mayo.edu
507-538-1707

Study Officials

  • Jeffrey Winters, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 23, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 15, 2013

Results First Posted

February 11, 2013

Record last verified: 2013-02

Locations

US(2)