Phase 1 Open Label, Dose Escalation Trial of Intracoronary Infusion of AB-1002 in Subjects With NYHA Class III Heart Failure
Abstract
This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart failure. 11 participants with non-ischemic cardiomyopathy were enrolled. All participants were followed until 12 months post treatment intervention, and then underwent long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).
Conditions: Congestive Heart Failure, Heart Failure, Heart Disease, Ischemic, Cardiovascular Diseases, Heart Failure, Systolic, Heart Failure，Congestive, Heart Arrhythmia, Heart Failure, Diastolic, Heart; Complications.
Primary outcome: Observed and change from baseline in Peak VO2; Observed and change from baseline in Echocardiographic assessment in Left Ventricular Ejection Fraction.
Enrollment: 11 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 11 participants or records.
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