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 |
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
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Utah Research is a major component in the life of the U benefiting...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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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
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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