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History of Changes for Study: NCT03071835
A Comparative Study of Subjects Past Their Final Follow-ON Visit (HYPERION)
Latest version (submitted April 19, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 1, 2017 None (earliest Version on record)
2 August 25, 2017 Study Status
3 February 15, 2018 Study Status, Eligibility and Outcome Measures
4 September 24, 2018 Study Status
5 June 13, 2019 Study Status
6 December 5, 2019 Study Status
7 September 17, 2020 Study Status
8 March 17, 2021 Study Status
9 October 5, 2021 Outcome Measures, Study Description, Study Status and Study Identification
10 April 19, 2022 Sponsor/Collaborators, Study Status and IPDSharing
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Study NCT03071835
Submitted Date:  March 1, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20150899
Brief Title: A Comparative Study of Subjects Past Their Final Follow-ON Visit (HYPERION)
Official Title: A Comparative Study of Subjects tHree to Nine Years Past thEiR fInal Follow- ON Visit
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2017
Overall Status: Enrolling by invitation
Study Start: June 23, 2016
Primary Completion: December 31, 2028 [Anticipated]
Study Completion: December 31, 2029 [Anticipated]
First Submitted: February 13, 2017
First Submitted that
Met QC Criteria:
March 1, 2017
First Posted: March 7, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
March 1, 2017
Last Update Posted: March 7, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Joshua M Hare
Responsible Party: Sponsor-Investigator
Investigator: Joshua M Hare
Official Title: Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute
Affiliation: University of Miami
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: Cardiomyopathies
Heart Diseases
Aging Frailty
Keywords: Stem Cells
Cardiovascular
Quality of Life
Cardiomyopathy
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Other
Biospecimen Retention: Samples With DNA
Biospecimen Description: Genetic testing will consist of collecting tissue and/or blood stored for future use.
Enrollment: 200 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
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)
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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

Exclusion Criteria:

  • Have known, serious radiographic contrast allergy
  • Have a history of drug or alcohol abuse within the past 24 months
Open or close this module Contacts/Locations
Study Officials: Joshua M Hare, Md
Principal Investigator
University of Miami
Locations: United States, Florida
ISCI / University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links: Description: Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine
Available IPD/Information:

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