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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiomyopathies; Aging Frailty

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
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • ISCI / University of Miami Miller School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 3, 5, 7, 9, and 13 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cardiac Function via Cardiac MRI	Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI	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	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	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	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	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)	at 3, 5, 7, 9, and 13 Years

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2016
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Stem Cells; Cardiovascular; Cardiomyopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Frailty; Cardiomyopathies
• Other Study ID Numbers: 20150899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No