Immunosuppression Clinical Trial
— CAROfficial title:
Cardiac Allograft Remodeling and Effects of Sirolimus on Its Progression
Verified date | August 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 42 |
Est. completion date | September 27, 2018 |
Est. primary completion date | September 27, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility | Inclusion Criteria: - All adult cardiac transplant recipients undergoing heart transplantation at UNMC/TNMC. Exclusion Criteria: - Adult cardiac transplant recipients with acute rejection (ISHLT R> grade 2) or acute infection. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
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University of Nebraska |
United States,
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* Note: There are 110 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety end points | Safety end points will be SRL side effects and prevalence of acute cellular cardiac rejection (ISHLT = 2R) and AMR. | Three years | |
Primary | Assessment in left ventricular hypertrophy | 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. | One year | |
Secondary | Assess outcomes | The secondary end points will be changes from baseline in LV function. | One year | |
Secondary | Access outcomes | Exercise performance (peak VO2, equivalent for carbon dioxide (VE/VCO2)and coronary vessel intimal thickening. | One year |
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