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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Juventas Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01961726
First received: October 8, 2013
Last updated: October 22, 2014
Last verified: October 2014

October 8, 2013
October 22, 2014
October 2013
August 2015   (final data collection date for primary outcome measure)
Impact of JVS-100 delivery on 6 minute walk distance 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 30 or 45 mg) delivered retrograde via the coronary sinus through the Oscor Venos Occlusion Balloon catheter on 6 minute walk distance compared to placebo at 4 months post dosing.
Same as current
Complete list of historical versions of study NCT01961726 on ClinicalTrials.gov Archive Site
Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up [ Time Frame: 4 and/or 12 months ] [ Designated as safety issue: No ]
To assess the impact of a single dose of JVS-100 on heart failure symptoms compared to placebo at 4 and/or 12 months post-dosing.
Same as current
Impact of JVS-100 delivery on quality of life measure 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 30 or 45 mg) delivered retrograde via the coronary sinus through the Oscor Venos Occlusion Balloon catheter on quality of life measure compared to placebo at 4 months post dosing.
Same as current
 
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure
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

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.

72 subjects with ischemic cardiomyopathy. The Phase I portion (n=12 subjects) will be open label. In the first cohort, six subjects will receive a single dose of 30 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 1, a safety assessment by the DSMC will be performed. Upon DSMC approval, the second cohort of six subjects will receive a single dose of 45 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 2, a safety assessment by the DSMC will be performed. Upon DSMC approval, up to 60 subjects will be randomized (1:1:1) to receive a single dose of 30 mg or 45 mg of JVS-100 or matching placebo.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Heart Failure
  • Biological: Placebo
    Coronary Sinus Delivery
  • Biological: 30 mg dose of JVS-100
    Coronary Sinus Delivery
  • Biological: 45 mg dose of JVS-100
    Coronary Sinus Delivery
  • Placebo Comparator: Placebo
    Interventions:
    • Biological: 30 mg dose of JVS-100
    • Biological: 45 mg dose of JVS-100
  • Experimental: 30 mg dose of JVS-100
    Interventions:
    • Biological: Placebo
    • Biological: 45 mg dose of JVS-100
  • Experimental: 45 mg dose of JVS-100
    Interventions:
    • Biological: Placebo
    • Biological: 30 mg dose of JVS-100
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subjects with a positive test results for hepatitis B/C and/or HIV will be excluded unless:

    • The subject is a carrier for hepatitis B/C but has never had an active flare
  • Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
  • 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 at day 0
  • Critical limb ischemia that limits the patients from completing 6 minute walk or treadmill testing
  • Subjects with severe chronic obstructive pulmonary disease (COPD)

    • Severe defined as having been hospitalized for COPD within the last 12 months
  • Any subject requiring home oxygen use for treatment of the symptoms of COPD
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01961726
JTCS-003
Yes
Juventas Therapeutics, Inc.
Juventas Therapeutics, Inc.
Not Provided
Not Provided
Juventas Therapeutics, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP