An Open Label Dose Escalation Study to Evaluate the Safety of a Single Escalating Dose of ACRX-100 Administered by Endomyocardial Injection to Cohorts of Adults With Ischemic Heart Failure
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Juventas Therapeutics, Inc.
- Enrollment
- 17
- Locations
- 4
- Primary Endpoint
- Number of Major Adverse Cardiac Events (MACE) at 30 days post-injection
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this Phase 1 study is to assess the safety, tolerability, and preliminary efficacy of single escalating doses of ACRX-100 delivered via endomyocardial injection in adults with ischemic heart failure.
Detailed Description
This open label, 16 subject, Phase 1 dose-escalation study will demonstrate the initial safety of using ACRX-100 to treat heart failure in subjects with ischemic cardiomyopathy. Safety will be tracked at each dose by documenting all adverse events (AEs), with the primary safety endpoint being the number of major cardiac AEs at 30 days. In each cohort (n=4 in low dose, n=6 each in mid and high dose), subjects will receive a single dose of ACRX-100. Preliminary efficacy will be evaluated by measuring the impact on cardiac function via standard echocardiography measurements, cardiac perfusion via SPECT imaging, and improvement in NYHA classification.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Greater than or equal to 18 years of age
- •NYHA Class III
- •Ischemic cardiomyopathy without an acute coronary syndrome within the last 6 months
- •Residual well-demarcated region of LV systolic dysfunction defined as at least 3 consecutive segments of abnormal wall motion by echocardiography read at the echocardiography core laboratory
- •LVEF less than or equal to 40% measured by echocardiography read at the echocardiography core laboratory
- •No left ventricular wall thickness less than 0.5 cm measured by echocardiography read at the echocardiography core laboratory
- •Mitral regurgitation of 0-2+ (inclusive) measured by echocardiography read at the echocardiography core laboratory
- •Subject has an implanted, functional AICD
- •Subject receiving stable optimal pharmacological therapy defined as:
- •ACE inhibitor and/or ARB, and Beta-blocker for 90 days with stable dose for 30 days unless contraindicate
Exclusion Criteria
- •Planned revascularization within 30 days following enrollment
- •Estimated Glomerular Filtration Rate \< 30 ml/min\*
- •Inability to undergo SPECT imaging
- •History of aortic valve regurgitation \> 2
- •Moderate/Severe aortic stenosis defined as AVA \<1.5 cm2
- •Presence of an artificial aortic valve
- •Subjects with aortic aneurysm \>3.8 cm
- •History of cancer with exception of basal cell carcinoma and following results on age appropriate cancer screenings
- •Subjects with persistent atrial fibrillation (per ACC/AHA/ESC guidelines, defined as recurrent AF episodes lasting longer than 7 days)
- •Subjects with Biventricular pacing device implant within the last 3 months OR previously implanted Biventricular pacing device with programming planned to be reoptimized following enrollment in this trial
Outcomes
Primary Outcomes
Number of Major Adverse Cardiac Events (MACE) at 30 days post-injection
Time Frame: 30 days post-injection