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

Ischemic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02115568
• Other study ID #: JTCS-005
• Status: Active, not recruiting
• Phase: N/A
• First received: April 7, 2014
• Last updated: April 14, 2014
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2014
• Source: Juventas Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Ischemic Heart Failure

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio
United States	Johns Hopkins University	Baltimore	Maryland
United States	Cardiology, P.C.	Birmingham	Alabama
United States	The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital	Cincinnati	Ohio
United States	Iowa Heart Center	Des Moines	Iowa
United States	University of Florida	Gainsville	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Kentucky Gill Heart Institute	Lexington	Kentucky
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Michigan Cardiovascular Institute	Saginaw	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	Washington University in St. Louis	St. Louis	Missouri
United States	Pepin Heart Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Juventas Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Newly diagnosed malignancies	A questionnaire will be used to track any newly diagnosed malignancies.	3 years	Yes