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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Ischemic Heart Failure

In brief

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.

Key facts

Study ID

NCT01643590

Run by

Juventas Therapeutics, Inc.

People needed

90

Starts

2012-07-01

Expected to finish

2014-11-01

Last updated by the study team

2014-02-07

Who can join

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

You may qualify if…

• Willing and able to sign informed consent
• Greater than or equal to 18 years of age
• Subjects with impaired 6 minute hall walk distance
• Impaired quality of life as measured by Minnesota LWHF questionnaire
• 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

You may not qualify if…

• 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):

Where it is running

• Cardiology PC — Birmingham, Alabama, United States
• University of Florida — Gainesville, Florida, United States
• Pepin Heart Institute — Tampa, Florida, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Michigan Cardiovascular Institute — Saginaw, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center — New York, New York, United States
• Summa Health System — Akron, Ohio, United States
• The Lindner Center at the Christ Hospital — Cincinnati, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Baylor Healthcare — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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