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

NCT01961726 | Unknown Phase 1 DMC

• 1 other identifier: JTCS-003
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Ischemic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up

  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.

  4 Months

Secondary Outcomes (1)

• Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up

  4 and/or 12 months

Other Outcomes (1)

• Impact of JVS-100 delivery on quality of life measure at 4 month follow-up

  4 Months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Biological: 30 mg dose of JVS-100; Biological: 45 mg dose of JVS-100

30 mg dose of JVS-100

EXPERIMENTAL

Biological: Placebo; Biological: 45 mg dose of JVS-100

45 mg dose of JVS-100

EXPERIMENTAL

Biological: Placebo; Biological: 30 mg dose of JVS-100

Interventions

Placebo BIOLOGICAL

Coronary Sinus Delivery

30 mg dose of JVS-100; 45 mg dose of JVS-100

30 mg dose of JVS-100 BIOLOGICAL

Coronary Sinus Delivery

45 mg dose of JVS-100; Placebo

45 mg dose of JVS-100 BIOLOGICAL

Coronary Sinus Delivery

30 mg dose of JVS-100; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Juventas Therapeutics, Inc.: lead

Study Sites (4)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

University of Florida

Gainsville, Florida, 32610-0277, United States

Location

The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

US (4)