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

Heart Diseases Clinical Trial

— HYPERION  

Official title:

A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071835
• Other study ID #: 20150899
• Status: Completed
• Start date: June 23, 2016
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging Frailty
• Cardiomyopathies
• Frailty
• Heart Diseases

Locations

Country	Name	City	State
United States	ISCI / University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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