Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure.



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:July 2012
End Date:July 2014
Contact:Joseph Pastore, PhD
Email:jpastore@juventasinc.com
Phone:216-678-9003

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A Phase II Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of JVS-100 Administered by Endomyocardial Injection to Cohorts of Adults With Ischemic Heart Failure


This is a randomized, double-blind, placebo controlled Phase II study is designed to assess
the safety and efficacy of using JVS-100 to treat heart failure.


90 subjects with ischemic cardiomyopathy will be randomized to receive a single dose of 15
or 30 mg of JVS-100 or matching placebo. Subjects will be randomized 1:1:1 to receive either
placebo, 15 mg or 30 mg of JVS-100. Subjects will be monitored overnight for 18-24 hours
post dose and have scheduled visits at 3 days post-injection for safety evaluations. All
subjects will be scheduled for follow-up visits at approximately 30 days (1 month), 120 days
(4 months), and 360 days (12 months) to assess safety and cardiac function.

Inclusion Criteria:

- Willing and able to sign informed consent

- Greater than or equal to 18 years of age

- Subjects with 6 minute hall walk distance ≤ 400 m limited only by cardiac fitness

- Minnesota LWHF questionnaire score ≥20 points

- 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 ≤40% measured by echocardiography read at the echocardiography core laboratory

- Must meet wall thickness criteria

- Subject has an implanted, functional AICD

- Subjects with diabetes must have had an ophthalmologist exam within the last year
showing no active proliferative retinopathy

- 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 contraindicated

- Diuretic in subjects with evidence of fluid retention

- ASA unless contraindicated

- Statin unless contraindicated

- Aldosterone antagonist per physician discretion

Exclusion Criteria:

- Planned revascularization within 30 days following enrollment

- Estimated Glomerular Filtration Rate < 30 ml/min*

- Signs of acute heart failure within 24 hours of scheduled injection

- History of aortic valve regurgitation classified as "moderate" or severe

- Moderate/Severe aortic stenosis defined as AVA <1.5 cm2

Note: Patient should not be excluded if the patient's medical records document that within
the last 6 months the patient has either:

- no aortic stenosis

- mild aortic stenosis

- normal aortic valve

- normal aortic pressure gradient

- aortic pressure gradient < 20 mmHg

- Presence of an artificial aortic valve

- Subjects with aortic aneurysm >3.8 cm

- Mitral regurgitation defined as "severe" measured by echocardiography at the
clinical site.

- Patients with planned mitral valve repair or replacement surgery

- Any patient with a history of cancer will be excluded unless:

- The cancer was limited to curable non-melanoma skin malignancies and/or

- The cancer was removed by a successful tumor resection, with or without radiation or
chemotherapy treatment, 5 years or more prior to enrollment in this study without
recurrence

Subjects must have the following results on age appropriate cancer screenings:

- Subjects age 50 or older have had a Fecal occult blood test (FOBT) or fecal
immunochemical test (FIT) that was negative within the last year

- Women age 30 or older have had a PAP test that was negative within the last 3 years

- Women age 40 or older have had a mammogram that was negative within the last year

- Men above age 45 have had a Prostate-Specific Antigen (PSA) blood test and digital
rectal examination (DRE) that was negative within the last year

- At the request of the site principal investigator, any subject with a non-negative
result thought to be due to a non-cancer-related condition will be evaluated by the
medical monitor for enrollment

Exclusion Criteria (ctd):

- Subjects with persistent or chronic atrial fibrillation will be excluded unless:

- A stable, regular heart rate is maintained with a biventricular pacemaker

- A stable, regular heart rate is maintained with a univentricular pacemaker
pacing less than or equal to 40% of the time

- 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%

- Inability to complete 6 minute walk or treadmill exercise test

- Participation in an experimental clinical trial within 30 days prior to enrollment

- Any subject who has been enrolled in a gene or stem cell therapy cardiac trial
within the last year

- 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 as described in Section
8.2.1 below

- Unwillingness of men capable of fathering a child to agree to use barrier
contraception or limit sexual activity as described in Section 8.2.1 below

- 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

- Any subject with a known existing LV thrombus or has an LV thrombus detected during
the screening period of this study.

- Subjects with Rutherford class 5 or 6 critical limb ischemia

- Subject with severe chronic obstructive pulmonary disease (COPD)

- Any subject requiring home oxygen use

- Subjects with a history of Systemic Lupus Erythematosus (SLE) flare

- History of drug or alcohol abuse within the last year

- A subject will be excluded if he/she is unfit for the trial based on the discretion
of the site Principal Investigator
We found this trial at
16
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Akron, Ohio 44304
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Birmingham, Alabama 35211
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Dallas, Texas 75226
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Des Moines, Iowa 50314
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Grand Rapids, Michigan 49503
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
215-662-4000
University of Pennsylvania Health System Today at Penn Medicine, someone will make a breakthrough. Someone...
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Saginaw, Michigan 48601
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Tampa, Florida 33613
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