Ischemic Heart FailureNCT02115568
Registry to Assess Safety for Subjects That Have Completed a Juventas Sponsored HF Protocol Under IND # 14203
An observational study of Ischemic Heart Failure, run by Juventas Therapeutics, Inc. at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Failure
- How many people
- 165 participants
- Where
- 14 sitesUnited States
- Study dates
- Jan 2014to Jan 2017
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participated in and completed a Juventas sponsored heart failure study under IND 14203
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Summa Health System
Akron, Ohio, 44309
Johns Hopkins University
Baltimore, Maryland, 21287
Cardiology, P.C.
Birmingham, Alabama, 35211
The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219
Iowa Heart Center
Des Moines, Iowa, 50026
University of Florida
Gainsville, Florida, 32610-0277
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
University of Kentucky Gill Heart Institute
Lexington, Kentucky, 40536
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Michigan Cardiovascular Institute
Saginaw, Michigan, 48601
University of Utah
Salt Lake City, Utah, 84132
Washington University in St. Louis
St Louis, Missouri, 63110
Pepin Heart Institute
Tampa, Florida, 33613
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Morbidity/Mortality
A questionnaire will be used to assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure.
Measured: 3 years
Secondary outcomes (1)
Newly diagnosed malignancies
A questionnaire will be used to track any newly diagnosed malignancies.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Juventas Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115568
- Sponsor's protocol ID
- JTCS-005
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02115568
- Acronym / sponsor ID
- JTCS-005
- Conditions
- Ischemic Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Juventas Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term safety follow-up | – | –To be eligible, subjects must have actively participated in a Juventas (JVS-100) sponsored trial under IND 14203. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Participated in and completed a Juventas sponsored heart failure study under IND 14203
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morbidity/Mortality
Time frame: 3 years
A questionnaire will be used to assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure.
1 secondary outcome
Newly diagnosed malignancies
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Failure, run by Juventas Therapeutics, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity/Mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.