Retro-HF

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

Retro-HF [NCT01961726]

Description:  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.

 

Biological: Placebo; Biological: 30 mg dose of JVS-100; Biological: 45 mg dose of JVS-100


Primary Investigator: Chung

Drug/Device Information
A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde delivery (via the coronary sinus)
ACL-01110Sk containing Human stromal cell-derived factor 1alpha (SDF-1) coding sequence
Phase I: Open-label single dose of JVS-100 30 mg or 45 mg. Phase 2: Randomized (1:1:1) to single dose of JVS-100 30 mg, 45 mg or placebo
Juventas Therapeutics, Inc.
Major Inclusion and Exclusion
LVEF ≤ 40% and receiving stable optimal pharmacological therapy
Ischemic cardiomyopathy and history of a MI
Can not have a permanent device placed in the coronary sinus (including a biventricular pacing coronary sinus lead)
No > 40% univentricular RV Pacing
No severe COPD or requiring home oxygen use for COPD
No GFR < 30
No HbA1c >10 %
Must be able to undergo 6 minute walk and treadmill exercise test