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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Juventas Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01643590
First received: July 10, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Failure
Biological: JVS-100 15 mg dose Injection
Biological: Placebo Injection
Biological: JVS-100 30 mg dose injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Juventas Therapeutics, Inc.:

Primary Outcome Measures:
  • Impact of JVS-100 injection on Six Minute Walk Distance (6MWD) at 4 month follow-up [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on 6 minute walk distance compared to placebo at 4 months post-dosing

  • Impact of JVS-100 injection on Quality of Life at 4 month follow-up [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on quality of life measured by the Minnesota Living with Heart Failure Questionnaire compared to placebo at 4 months post-dosing


Secondary Outcome Measures:
  • Impact of JVS-100 Injection on Quality of Life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on quality of life measured by the Minnesota Living with Heart Failure Questionnaire compared to placebo at 12 months post-dosing

  • Impact of JVS-100 Injection on NYHA class [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on NYHA class compared to placebo at 4 months post-dosing

  • Impact of JVS-100 Injection on LVEF [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on Left Ventricular Ejection Fraction as measured by echocardiography compared to placebo at 4 months post-dosing

  • Impact of JVS-100 Injection on Time to First Heart Failure Decompensation [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the time to first heart failure decompensation compared to placebo

  • Impact of JVS-100 Injection on Major Adverse Cardiac Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of major adverse cardiac events (MACE) compared to placebo

  • Impact of JVS-100 Injection on number of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of adverse events compared to placebo

  • Impact of JVS-100 Injection on number of serious adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of serious adverse events compared to placebo


Estimated Enrollment: 90
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Biological: Placebo Injection
Intramyocardial Injection
Experimental: 15 mg dose of JVS-100
15 mg dose of JVS-100
Biological: JVS-100 15 mg dose Injection
Intramyocardial Injection
Experimental: 30 mg dose of JVS-100
30 mg dose of JVS-100
Biological: JVS-100 30 mg dose injection
Intramyocardial Injection

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643590

Locations
United States, Alabama
Cardiology PC
Birmingham, Alabama, United States, 35211
United States, Florida
University of Florida
Gainesville, Florida, United States, 32603
Pepin Heart Institute
Tampa, Florida, United States, 33613
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50026
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Michigan Cardiovascular Institute
Saginaw, Michigan, United States, 48601
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center
New York, New York, United States, 10476
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44309
The Lindner Center at the Christ Hospital
Cincinnati, Ohio, United States, 45238
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor Healthcare
Dallas, Texas, United States, 75226
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Juventas Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Juventas Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01643590     History of Changes
Other Study ID Numbers: JTCS-004
Study First Received: July 10, 2012
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014