A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde delivery to cohorts of adults with Ischemic Heart Failure.
72 subjects with ischemic cardiomyopathy. The Phase I portion (n=12 subjects) will be open label. In the first cohort, six subjects will receive a single dose of 30 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 1, a safety assessment by the DSMC will be performed. Upon DSMC approval, the second cohort of six subjects will receive a single dose of 45 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 2, a safety assessment by the DSMC will be performed. Upon DSMC approval, up to 60 subjects will be randomized (1:1:1) to receive a single dose of 30 mg or 45 mg of JVS-100 or matching placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Coronary Sinus Delivery
Coronary Sinus Delivery
Coronary Sinus Delivery
Cardiology, P.C.
Birmingham, Alabama, United States
University of Florida
Gainsville, Florida, United States
The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
University of Utah
Salt Lake City, Utah, United States
Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
To investigate the impact of single doses of JVS-100 (either 30 or 45 mg) delivered retrograde via the coronary sinus through the Oscor Venos Occlusion Balloon catheter on 6 minute walk distance compared to placebo at 4 months post dosing.
Time frame: 4 Months
Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up
To assess the impact of a single dose of JVS-100 on heart failure symptoms compared to placebo at 4 and/or 12 months post-dosing.
Time frame: 4 and/or 12 months
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