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

• Conditions: Ischemic Heart Failure

• Registration Number: NCT02115568
• Lead Sponsor: Juventas Therapeutics, Inc.

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.

Detailed Description

This Registry will assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure and track any newly diagnosed malignancies. The logistics of the study are as follows: to be eligible, subjects must have actively participated in a Juventas sponsored trial under IND 14203. After consent, subjects will be followed for up to three years post receipt of investigational product during which time they will receive phone calls (every 3 months) from the study site asking about their health. Questions will be aimed at cardiovascular related events including:

* Hospitalizations

* ER Visits

* Unscheduled visits with Cardiologist

* Newly diagnosed malignancies Serious Adverse Events (SAEs) will not be reported in this study; however, data pertaining to such events will be captured (i.e. date of admission and diagnosis.). Data will be captured on paper CRFs, collected by Juventas (or their designee) and will be entered into a clinical database for analysis.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Study First Posted: 2014-04-16
• Last Update Posted: 2014-04-16
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity/Mortality	3 years	A questionnaire will be used to assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure.

Secondary Outcome Measures

Name	Time	Method
Newly diagnosed malignancies	3 years	A questionnaire will be used to track any newly diagnosed malignancies.

Trial Locations

Locations (14)

Cardiology, P.C.; 🇺🇸 Birmingham, Alabama, United States

University of Florida; 🇺🇸 Gainsville, Florida, United States

Pepin Heart Institute; 🇺🇸 Tampa, Florida, United States

Iowa Heart Center; 🇺🇸 Des Moines, Iowa, United States

University of Kentucky Gill Heart Institute; 🇺🇸 Lexington, Kentucky, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Michigan Cardiovascular Institute; 🇺🇸 Saginaw, Michigan, United States

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Washington University in St. Louis; 🇺🇸 St. Louis, Missouri, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

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