A Comparative Study of Subjects Past Their Final Follow-ON Visit (HYPERION)
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|ClinicalTrials.gov Identifier: NCT03071835|
Recruitment Status : Enrolling by invitation
First Posted : March 7, 2017
Last Update Posted : December 9, 2019
|Condition or disease|
|Cardiomyopathies Heart Diseases Aging Frailty|
A comparative study to follow subjects who received stem cell therapies three, five, seven, and nine 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 or seven-year visit may receive informed consent at the year nine visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||A Comparative Study of Subjects tHree to Nine Years Past thEiR fInal Follow- ON Visit|
|Actual Study Start Date :||June 23, 2016|
|Estimated Primary Completion Date :||December 31, 2028|
|Estimated Study Completion Date :||December 31, 2029|
- Continued Improvement in subject's symptoms [ Time Frame: at 3, 5, 7 and 9 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.
- Change in Cardiac Function via Cardiac MRI [ Time Frame: at 3, 5, 7 and 9 Years ]Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI
- Change in Cardiac Function via Cardiac CT [ Time Frame: at 3, 5, 7 and 9 Years ]Evaluate Cardiac Function for changes, positive and negative via Cardiac CT
- Evaluate Functional Capacity via the NYHA Class [ Time Frame: at 3, 5, 7 and 9 Years ]Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination
- Evaluate Functional Capacity via the Six Minute Walk Test [ Time Frame: at 3, 5, 7 and 9 Years ]Evaluate Functional Capacity via the Six Minute Walk Test
- Evaluate change in Quality of Life via the Minnesota Living with Heart Failure [ Time Frame: at 3, 5, 7 and 9 Years ]Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire
- Evaluate change in Symptoms via cardiac events [ Time Frame: at 3, 5, 7 and 9 Years ]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)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071835
|United States, Florida|
|ISCI / University of Miami Miller School of Medicine|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Joshua M Hare, Md||University of Miami|