This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.
The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
12-20 transendocardial injections of 0.4 mL of ixmyelocel-T per injection into the left ventricle.
12-20 transendocardial injections of 0.4 mL of vehicle control per injection into the left ventricle.
Cardiology, P.C. & Center for Therapeutic Angiogenesis
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Scripps Clinic
La Jolla, California, United States
Average number of clinical events over 12 months post-treatment.
The primary endpoint will assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average number of events per patient over 12 months post-treatment in each treatment arm (total number events in each arm/total number of patients in each arm). The events include: all-cause deaths, cardiovascular hospitalizations, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure. The clinical events used in this endpoint will be adjudicated by an independent clinical endpoint committee who are blinded to treatment.
Time frame: 12 Months
The win ratio of the hierarchical occurrence of all-cause deaths/left ventricular assist device (LVAD) implant/heart transplant, cardiovascular hospitalizations, and unplanned outpatient and ED interventions to treat ADHF
This is a composite end point. This endpoint will be primarily assessed excluding events considered to be related to administration of IP. An analysis including IP administration-related events will also be conducted as part of the sensitivity analyses.
Time frame: 12 Months
Change from baseline to 12 months post-treatment in 6-minute walk test.
A secondary objective will be to evaluate the changes from baseline to 12 months post-treatment in the distance walked as measured by the 6-minute walk test.
Time frame: 12 Months
Change from baseline to 12 months post-treatment in left ventricular function as evaluated by echocardiography.
A secondary objective will be to evaluate the change in left ventricular function as measured by echocardiography for left ventricular ejection fraction (LVEF).
Time frame: 12 Months
Change from baseline to 12 months post-treatment in quality of life.
A secondary objective will be to evaluate the change in quality of life (total score) in patients treated with ixmyelocel-T compared to placebo using the Minnesota Living with Heart Failure Questionnaire.
Time frame: 12 Months
Change from baseline to 12 months post-treatment in NYHA Classification.
A secondary objective will be to evaluate the change from baseline to Month 12 in NYHA Classification in patients treated with ixmyelocel-T compared to placebo.
Time frame: 12 Months
Percent of patients with adverse events.
A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with DCM from time of aspiration through 12 months post-treatment/follow-up by % of patients with adverse events.
Time frame: 12 Months
Percent of patients with major adverse cardiac events (MACE).
A secondary objective will be to evaluate the overall safety and tolerability of ixmyelocel-T versus placebo in patients with DCM by the percentage of patients who experience MACE events. MACE events include: unstable angina requiring hospitalization, myocardial infarction, stroke, worsening heart failure requiring hospitalization, VAD implantation, heart transplant, resuscitated sudden death, and cardiovascular death.
Time frame: 12 Months
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