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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: Clinical Trial Phase 1 study, sponsored by University of Nebraska.
NCT01889992 is a Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary end point will be the change from baseline in LV mass indexed to height in meters 2.7 and LV concentricity as assessed by MRI during 12 months of the treatment.
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 |
Why NCT01889992 stopped before completion
NCT01889992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 5 interventions - of which Cardiac MRI is the first listed.
NCT01889992 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01889992's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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