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.
Brief Title
Registry to Assess Safety for Subjects That Have Completed a Juventas Sponsored HF Protocol Under IND # 14203
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.
* 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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Ischemic Heart Failure
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Participated in and completed a Juventas sponsored heart failure study under IND 14203
* Participated in and completed a Juventas sponsored heart failure study under IND 14203
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02115568
Org Class
Industry
Org Full Name
Juventas Therapeutics, Inc.
Org Study Id
JTCS-005
Overall Status
Unknown status
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
A questionnaire will be used to assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure.
Outcome Measure
Morbidity/Mortality
Outcome Time Frame
3 years
Secondary Outcomes
Outcome Description
A questionnaire will be used to track any newly diagnosed malignancies.
Outcome Time Frame
3 years
Outcome Measure
Newly diagnosed malignancies
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jooyoung Shin
Investigator Email
jushin@montefiore.org
Investigator Phone