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

NCT01643590 | Unknown Phase 2 DMC

• 1 other identifier: JTCS-004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Ischemic Heart Failure

Outcome Measures

Primary Outcomes (2)

• Impact of JVS-100 injection on Six Minute Walk Distance (6MWD) at 4 month follow-up

  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

  4 Months

• Impact of JVS-100 injection on Quality of Life at 4 month follow-up

  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

  4 months

Secondary Outcomes (7)

• Impact of JVS-100 Injection on Quality of Life

  12 Months

• Impact of JVS-100 Injection on NYHA class

  4 months

• Impact of JVS-100 Injection on LVEF

  4 months

• Impact of JVS-100 Injection on Time to First Heart Failure Decompensation

  Up to 12 months

• Impact of JVS-100 Injection on Major Adverse Cardiac Events

  Up to 12 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Biological: Placebo Injection

15 mg dose of JVS-100

EXPERIMENTAL

15 mg dose of JVS-100

Biological: JVS-100 15 mg dose Injection

30 mg dose of JVS-100

EXPERIMENTAL

30 mg dose of JVS-100

Biological: JVS-100 30 mg dose injection

Interventions

JVS-100 15 mg dose Injection BIOLOGICAL

Intramyocardial Injection

15 mg dose of JVS-100

Placebo Injection BIOLOGICAL

Intramyocardial Injection

Placebo

JVS-100 30 mg dose injection BIOLOGICAL

Intramyocardial Injection

30 mg dose of JVS-100

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
• 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

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

Sponsors & Collaborators

• Juventas Therapeutics, Inc.: lead

Study Sites (16)

Cardiology PC

Birmingham, Alabama, 35211, United States

Location

University of Florida

Gainesville, Florida, 32603, United States

Location

Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50026, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Michigan Cardiovascular Institute

Saginaw, Michigan, 48601, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

New York, New York, 10476, United States

Location

Summa Health System

Akron, Ohio, 44309, United States

Location

The Lindner Center at the Christ Hospital

Cincinnati, Ohio, 45238, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor Healthcare

Dallas, Texas, 75226, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 10, 2012
• First Posted: July 18, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

US (16)