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NCT01889992 · ClinicalTrials.gov registry record · Phase 1
Cardiac Allograft Remodeling and Effects of Sirolimus
A Phase 1 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01889992 is a Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 42 participants.
The verdict
NCT01889992, a Phase 1 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
Cardiac allograft remodeling causes poor quality of life, allograft failure and increased mortality after heart transplantation. Risk factors for cardiac allograft remodeling and its progression are poorly defined and there is a need for effective interventions.This is a multi-factorial phenomenon, associated with various immunological and non-immunological factors. Animal studies suggest M-TOR inhibition attenuates cardiac allograft remodeling secondary to down-regulation of M-TOR downstream targets and increased autophagy. There is a paucity of data regarding effect of Sirolimus, a M-TOR inhibitor, on human heart remodeling. This aim of the proposal to identify the prevalence of cardiac allograft remodeling on current immunosuppressive strategies and determine risk factors for its development. It will also identify molecular pathways associated with cardiac allograft remodeling and determine the impact of Sirolimus on these pathways.
Interventions
- RADIATION Cardiac MRI
- PROCEDURE Coronary angiography with IVUS
- OTHER Cardiac Allograft Remodeling
- DRUG M-TOR Immunosuppression
- PROCEDURE Cardiac Biopsy C4D stain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-04-24 |
| Est. Completion | 2018-09-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01889992
The ClinicalTrials.gov registry entry for NCT01889992 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cardiac MRI is the first listed.
NCT01889992 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01889992 about?
NCT01889992 is a clinical study titled "Cardiac Allograft Remodeling and Effects of Sirolimus". Cardiac allograft remodeling causes poor quality of life, allograft failure and increased mortality after heart transplantation. Risk factors for cardiac allograft remodeling and its progression are poorly defined and there is a need for effective interventions.This is a multi-factorial phenomenon, ...
What is the current status of trial NCT01889992?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2013-04-24. Estimated completion is 2018-09-27.
What interventions are being tested in trial NCT01889992?
The interventions under investigation include: Cardiac MRI (RADIATION), Coronary angiography with IVUS (PROCEDURE), Cardiac Allograft Remodeling (OTHER), M-TOR Immunosuppression (DRUG), Cardiac Biopsy C4D stain (PROCEDURE).
Who is sponsoring clinical trial NCT01889992?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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