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

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Ischemic Heart Failure

In brief

A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde delivery to cohorts of adults with Ischemic Heart Failure.

Key facts

Study ID

NCT01961726

Run by

Juventas Therapeutics, Inc.

People needed

72

Starts

2013-10-01

Expected to finish

2015-08-01

Last updated by the study team

2014-10-23

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
• Poor quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ)
• Impaired 6 Minute Walk test
• 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
• 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
• Subject must not have a permanent device placed in the coronary sinus at the time of enrollment *As defined as no more than 50% change in dose

You may not qualify if…

• Planned revascularization within 30 days following enrollment
• Note: if an angiographic study has been performed within the last year and the subject is enrolled, the angiography study report should be included as part of the subject's file
• Estimated Glomerular Filtration Rate < 30 ml/min*
• Signs of acute heart failure within 24 hours of scheduled infusion
• History of aortic valve regurgitation classified as "moderate-severe" or worse
• Patients will be excluded who have:
• Known prior trauma to the coronary sinus
• In dwelling instrumentation that may hamper coronary venous catheterization, including a biventricular pacing coronary sinus lead
• 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 with persistent (per ACC/AHA/EEC guidelines)53, defined as recurrent AF episodes lasting longer than 7 days) 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
• Inability to undergo 6 minute walk or treadmill exercise test
• Previous solid organ transplant
• Subjects with greater than 40% univentricular RV Pacing
• Subjects with uncontrolled diabetes defined as HbA1c >10 %
• 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 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

Where it is running

• Cardiology, P.C. — Birmingham, Alabama, United States
• University of Florida — Gainsville, Florida, United States
• The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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