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Completed

NCT Number: NCT03071835

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ISCI / University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: HYPERION

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2017
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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