Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III… (NCT05598333) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure
United States150 participantsStarted 2023-10-20
Plain-language summary
This is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center trial study to evaluate the safety and efficacy of a single dose of AB-1002, administered via antegrade intracoronary artery infusion, in males and females age \>18 years with non-ischemic cardiomyopathy and NYHA Class III symptoms of HF.
Subjects will be randomized into one of three treatment groups in a 1:1:1
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must be age ≥18 years of age, at the time of signing the informed consent.
✓. Chronic non-ischemic cardiomyopathy
✓. 15% ≤ LVEF ≤ 35% by transthoracic echocardiography (TTE) at screening
✓. 6MWT \>50 meters
✓. Medically stable, NYHA Class III HF for a minimum of 4 weeks while on appropriate medical therapy (defined below) including, but not limited to:
✓. Beta blocker therapy and ACE inhibitor or angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy (Entresto) for ≥ 90 days prior to enrollment.
✓. Cardiac resynchronization therapy (Zareba et al 2011), if clinically indicated, must have been implanted ≥ 90 days prior to enrollment. Internal cardioverter defibrillator (ICD) must be implanted, if clinically indicated ≥ 30 days prior to enrollment.
✓. Women of childbearing potential must use at least one of the following acceptable birth control methods throughout the study and for 6 months after IP administration:
Exclusion criteria
✕. Chronic ischemic cardiomyopathy secondary to obstructive coronary artery disease
✕0. Intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous cardiac assist device therapy within 30 days prior to enrollment
✕2. Cardiac surgery or percutaneous coronary intervention (PCI) within 30 days prior to screening
✕3. Uncorrected Third degree heart block
✕4. Clinically significant myocardial infarction (MI) in the judgment of the subject's physician (e.g., ST elevation MI \[STEMI\] or large non-STEMI) within 6 months prior to enrollment
✕5. Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt
✕6. Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LV reduction surgery, heart transplant, conventional revascularization procedure, or valvular repair within 3 months of IP dosing in judgement of investigator.