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

A Registry to Assess the Ongoing Safety for Subjects That Have Been Randomized and Completed a Juventas Sponsored Heart Failure Protocol Under IND # 14203

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Heart Failure

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 Type: Observational
• Enrollment (Anticipated): 165

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Cardiology, P.C.
  • Florida
    • Gainsville, Florida, United States, 32610-0277
      • University of Florida
    • Tampa, Florida, United States, 33613
      • Pepin Heart Institute
  • Iowa
    • Des Moines, Iowa, United States, 50026
      • Iowa Heart Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Gill Heart Institute
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Michigan
    • Saginaw, Michigan, United States, 48601
      • Michigan CardioVascular Institute
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke'S Hospital of Kansas City
    • St. Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Akron, Ohio, United States, 44309
      • Summa Health System
    • Cincinnati, Ohio, United States, 45219
      • The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Long-term safety follow-up; To be eligible, subjects must have actively participated in a Juventas (JVS-100) sponsored trial under IND 14203.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newly diagnosed malignancies	A questionnaire will be used to track any newly diagnosed malignancies.	3 years

Collaborators and Investigators

• Sponsor: Juventas Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Estimate): April 16, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: JTCS-005