Clinical trial NCT02115568: Registry to Assess Safety for Subjects That Have Completed a Juventas Sponsored HF Protocol Under IND # 14203
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Heart Failure
Lead sponsor: Juventas Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-16
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morbidity/Mortality
timeFrame: 3 years
Secondary outcomes:
measure: Newly diagnosed malignancies
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: Gainsville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Institute
state: Florida
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Gill Heart Institute
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Saginaw
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: