CardiomyopathiesHYPERIONNCT03071835
A Comparative Study of Subjects Past Their Final Follow-ON Visit
An observational study of Cardiomyopathies and Heart Diseases, run by University of Miami at 1 site in United States.
Trial summary
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Heart Diseases, Aging Frailty
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2016to 1 Oct 2023
- 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 population for this study will consist of subjects who previously participated at an ISCI Trial and who are able to consent to being followed past their Follow-On visit.
Who may be able to join
- Be 18 years of age and older
- Provide written informed consent
- Have been previously enrolled or currently participating in an investigator-initiated cardiovascular trial at ISCI (In cases where participants are currently enrolled in another clinical trial they are still able to participate concurrently in this trial).
Who cannot join
- Have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo MRI or CT.
- Have a history of drug or alcohol abuse within the past 24 months
Trial locations and contacts
1 site in 1 country.
United States1 site
ISCI / University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Read the detailed description
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Subjects will be followed during the study depending on the initial visit for this trial. The time point at which they are followed will depend on the subject's injection date in the previous trial. Depending on the subjects first treatment date (Day of injection) in the previous Interdisciplinary Stem Cell Institute (ISCI) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. Those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.
- Conditions
- Cardiomyopathies, Heart Diseases, Aging Frailty
- Keywords
- Stem Cells, Cardiovascular, Quality of Life, Cardiomyopathy
- Medical subject headings
- Cardiomyopathies, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Continued Improvement in subject's symptoms
Demonstrate change of subject's symptoms by assessing cardiac events over an extended period of time following participation in an ISCI cardiac trial where the subject received Investigational product.
Measured: at 3, 5, 7, 9, and 13 Years
Secondary outcomes (6)
Change in Cardiac Function via Cardiac MRI
Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI
Measured: at 3, 5, 7, 9, and 13 Years
Change in Cardiac Function via Cardiac CT
Evaluate Cardiac Function for changes, positive and negative via Cardiac CT
Measured: at 3, 5, 7, 9, and 13 Years
Evaluate Functional Capacity via the NYHA Class
Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination
Measured: at 3, 5, 7, 9, and 13 Years
Evaluate Functional Capacity via the Six Minute Walk Test
Evaluate Functional Capacity via the Six Minute Walk Test
Measured: at 3, 5, 7, 9, and 13 Years
Evaluate change in Quality of Life via the Minnesota Living with Heart Failure
Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire
Measured: at 3, 5, 7, 9, and 13 Years
Evaluate change in Symptoms via cardiac events
Evaluate Progression or Regression of disease (i.e. death, Left Ventricular Assist Device (LVAD), heart transplant and/or continuous intravenous infusion therapy (dobutamine, Milrinone, etc)
Measured: at 3, 5, 7, 9, and 13 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start23 Jun 2016
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua M Hare, University of Miami
- Investigators
- Joshua M Hare, Md, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071835
- Sponsor's protocol ID
- 20150899
- Acronym
- HYPERION
- Status last verified
- Oct 2023
- First submitted
- 13 Feb 2017
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)
- ClinicalTrials.gov ID
- NCT03071835
- Acronym / sponsor ID
- HYPERION / 20150899
- Conditions
- Cardiomyopathies, Heart Diseases, Aging Frailty
- Keywords
- Stem Cells, Cardiovascular, Quality of Life, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 7 Mar 2017 (actual)
- 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.
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Detailed description
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Subjects will be followed during the study depending on the initial visit for this trial. The time point at which they are followed will depend on the subject's injection date in the previous trial. Depending on the subjects first treatment date (Day of injection) in the previous Interdisciplinary Stem Cell Institute (ISCI) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. Those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population for this study will consist of subjects who previously participated at an ISCI Trial and who are able to consent to being followed past their Follow-On visit.
Key inclusion criteria (3 listed)
- Be 18 years of age and older
- Provide written informed consent
- Have been previously enrolled or currently participating in an investigator-initiated cardiovascular trial at ISCI (In cases where participants are currently enrolled in another clinical trial they are still able to participate concurrently in this trial).
Key exclusion criteria (2 listed)
- Have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo MRI or CT.
- Have a history of drug or alcohol abuse within the past 24 months
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
Continued Improvement in subject's symptoms
Time frame: at 3, 5, 7, 9, and 13 Years
Demonstrate change of subject's symptoms by assessing cardiac events over an extended period of time following participation in an ISCI cardiac trial where the subject received Investigational product.
6 secondary outcomes
Change in Cardiac Function via Cardiac MRI
Time frame: at 3, 5, 7, 9, and 13 Years
Change in Cardiac Function via Cardiac CT
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate Functional Capacity via the NYHA Class
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate Functional Capacity via the Six Minute Walk Test
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate change in Quality of Life via the Minnesota Living with Heart Failure
Time frame: at 3, 5, 7, 9, and 13 Years
Evaluate change in Symptoms via cardiac events
Time frame: at 3, 5, 7, 9, and 13 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Interdisciplinary Stem Cell Institute at the University of Miami Miller School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Joshua M Hare, Md principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Heart Diseases, run by University of Miami at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Continued Improvement in subject's symptoms (time frame: at 3, 5, 7, 9, and 13 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 18 Oct 2023.