HYPERION: A Comparative Study of Subjects Past Their Final Follow-ON Visit

Sponsor
University of Miami (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03071835
Collaborator
(none)
200
1
162.3
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)
    Actual Study Start Date :
    Jun 23, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2029
    Anticipated Study Completion Date :
    Dec 31, 2029

    Outcome Measures

    Primary Outcome Measures

    1. Continued Improvement in subject's symptoms [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.

    Secondary Outcome Measures

    1. Change in Cardiac Function via Cardiac MRI [at 3, 5, 7, 9, and 13 Years]

      Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI

    2. Change in Cardiac Function via Cardiac CT [at 3, 5, 7, 9, and 13 Years]

      Evaluate Cardiac Function for changes, positive and negative via Cardiac CT

    3. Evaluate Functional Capacity via the NYHA Class [at 3, 5, 7, 9, and 13 Years]

      Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination

    4. Evaluate Functional Capacity via the Six Minute Walk Test [at 3, 5, 7, 9, and 13 Years]

      Evaluate Functional Capacity via the Six Minute Walk Test

    5. Evaluate change in Quality of Life via the Minnesota Living with Heart Failure [at 3, 5, 7, 9, and 13 Years]

      Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire

    6. Evaluate change in Symptoms via cardiac events [at 3, 5, 7, 9, and 13 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ISCI / University of Miami Miller School of Medicine Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Joshua M Hare, Md, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Joshua M Hare, Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute, University of Miami
    ClinicalTrials.gov Identifier:
    NCT03071835
    Other Study ID Numbers:
    • 20150899
    First Posted:
    Mar 7, 2017
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Joshua M Hare, Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute, University of Miami
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2022