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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 : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Brief Summary:
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.

Condition or disease
Cardiomyopathies Heart Diseases Aging Frailty

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Other
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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
Genetic testing will consist of collecting tissue and/or blood stored for future use.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United States, Florida
ISCI / University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
Joshua M Hare
Investigators
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Principal Investigator: Joshua M Hare, Md University of Miami

Additional Information:
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Responsible Party: Joshua M Hare, Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute, University of Miami
ClinicalTrials.gov Identifier: NCT03071835     History of Changes
Other Study ID Numbers: 20150899
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joshua M Hare, University of Miami:
Stem Cells
Cardiovascular
Quality of Life
Cardiomyopathy

Additional relevant MeSH terms:
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Heart Diseases
Cardiomyopathies
Frailty
Cardiovascular Diseases
Pathologic Processes