Registry to Assess Safety for Subjects That Have Completed a Juventas Sponsored HF Protocol Under IND # 14203

NCT02115568 | Unknown

• 1 other identifier: JTCS-005
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 14

Brief Summary

This is an exploratory registry that will include subjects who have been randomized to receive JVS-100 treatment (at one of multiple doses) or placebo by one of a number of delivery systems (e.g. endomyocardial injection, retrograde infusion) in a previous Juventas clinical trial.

Conditions

Ischemic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Morbidity/Mortality

  A questionnaire will be used to assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure.

  3 years

Secondary Outcomes (1)

• Newly diagnosed malignancies

  3 years

Study Arms (1)

Long-term safety follow-up

To be eligible, subjects must have actively participated in a Juventas (JVS-100) sponsored trial under IND 14203.

Eligibility Criteria

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

Study Population

The patient population eligible for the proposed Registry will be subjects who have completed a Juventas sponsored heart failure study under IND 14203. The patient population will primarily be comprised of symptomatic systolic heart failure patients due to ischemic etiology.

You may qualify if:

• Participated in and completed a Juventas sponsored heart failure study under IND 14203

You may not qualify if:

• Unwillingness to sign informed consent form
• Unwillingness or inability to receive phone calls for required follow up assessments
• Subjects actively participating in another regenerative medicine trial should be discussed with sponsor prior to enrollment

Sponsors & Collaborators

• Juventas Therapeutics, Inc.: lead

Study Sites (14)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

University of Florida

Gainsville, Florida, 32610-0277, United States

Location

Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50026, United States

Location

University of Kentucky Gill Heart Institute

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Michigan Cardiovascular Institute

Saginaw, Michigan, 48601, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, 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

Summa Health System

Akron, Ohio, 44309, United States

Location

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

Cincinnati, Ohio, 45219, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 16, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

US (14)