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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071835
Recruitment Status : Enrolling by invitation
First Posted : March 7, 2017
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Tracking Information
First Submitted Date February 13, 2017
First Posted Date March 7, 2017
Last Update Posted Date April 27, 2022
Actual Study Start Date June 23, 2016
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2021)
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.
Original Primary Outcome Measures
 (submitted: March 1, 2017)
Continued Improvement in subject's symptoms [ Time Frame: at 3, 5, 7 and 9 Years ]
Demonstrate change of subjects over an extended period of time following participation.
Change History
Current Secondary Outcome Measures
 (submitted: October 5, 2021)
  • Change in Cardiac Function via Cardiac MRI [ Time Frame: at 3, 5, 7, 9, and 13 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, 9, and 13 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, 9, and 13 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, 9, and 13 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, 9, and 13 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, 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)
Original Secondary Outcome Measures
 (submitted: March 1, 2017)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Comparative Study of Subjects Past Their Final Follow-ON Visit
Official Title A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Genetic testing will consist of collecting tissue and/or blood stored for future use.
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.
Condition
  • Cardiomyopathies
  • Heart Diseases
  • Aging Frailty
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: March 1, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2029
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03071835
Other Study ID Numbers 20150899
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Joshua M Hare, University of Miami
Original Responsible Party Same as current
Current Study Sponsor University of Miami
Original Study Sponsor Joshua M Hare
Collaborators Not Provided
Investigators
Principal Investigator: Joshua M Hare, Md University of Miami
PRS Account University of Miami
Verification Date April 2022