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

Completed · Phase 1

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01082094

Run by

Juventas Therapeutics, Inc.

People needed

17

Starts

2010-02-01

Expected to finish

2012-01-01

Last updated by the study team

2012-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Positive pregnancy test (serum βHCG) in women of childbearing potential and/or unwillingness to use contraceptives or limit sexual activity
• Unwillingness of men capable of fathering a child to agree to use barrier contraception or limit sexual activity
• Subjects who are breast feeding
• Subjects with a positive test results for hepatitis B/C and/or HIV
• Total Serum Bilirubin >4.0 mg/dl
• Aspartate aminotransferase (AST) > 120 IU/L
• Alanine aminotransferase (ALT) > 135 IU/L
• Alkaline phosphatase (ALP): >300 IU/L
• Clinically significant elevations in PT or PTT relative to laboratory norms
• Proteinuria > 3.5 g/L

Where it is running

• Cardiology, PC — Birmingham, Alabama, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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