Study to Evaluate the Safety of a Single Escalating Dose of ACRX-100 in Adults With Ischemic Heart Failure

NCT01082094 | Completed Phase 1 DMC

• 1 other identifier: JTCS-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Failure

Keywords

Ischemic heart failure; Congestive heart failure; Stromal cell-derived factor 1; SDF-1; Gene therapy

Outcome Measures

Primary Outcomes (1)

• Number of Major Adverse Cardiac Events (MACE) at 30 days post-injection

  30 days post-injection

Study Arms (1)

ACRX-100

EXPERIMENTAL

Cohort 1 = Low dose Cohort 2 = Middle dose Cohort 3 = High Dose

Biological: ACRX-100

Interventions

ACRX-100 BIOLOGICAL

Three cohorts (16 total subjects) will be studied. There will be no concurrent controls. The dose will be escalated by increasing the total amount of ACRX-100 delivered per subject from low dose (n=4 subjects) to middle dose (n=6 subjects) to high dose (n=6 subjects). ACRX-100 will be injected directly into the myocardium as a single dose at multiple sites through a percutaneous, left ventricular approach using a needle injection catheter.

ACRX-100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Diuretic in subjects with evidence of fluid retention ASA unless contraindicated
• Statin unless contraindicated
• Aldosterone antagonist per physician discretion unless contraindicated
• Subjects with found diagnosis of diabetes must have had an ophthalmologist exam within the last year showing no active proliferative retinopathy

You may not qualify if:

• 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
• Previous solid organ transplant
• Subjects with greater than 40% univentricular RV Pacing
• Subjects with uncontrolled diabetes defined as HbA1c \>9.0%
• Participation in an experimental clinical trial within 30 days prior to enrollment
• Life expectancy of less than 1 year

Sponsors & Collaborators

• Juventas Therapeutics, Inc.: lead

Study Sites (4)

Cardiology, PC

Birmingham, Alabama, 35211, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Douglas Losordo, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 8, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

US (4)