Effect of mTOR Inhibition & Other Metabolism Modulating Interventions on the Elderly [SubStudy Rapa & cMRI to Evaluate Cardiac Function] (mTOR)
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|ClinicalTrials.gov Identifier: NCT04742777|
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : May 25, 2022
The ability to mount an effective immune response declines with age, leaving the elderly increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug to prevent transplant rejection, increases the lifespan and healthspan of mice and ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in laboratory animals. Investigators are conducting a translational trial to test whether rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95).
Substudy E will evaluate the Rapamycin and Cardiac Function.
|Condition or disease||Intervention/treatment||Phase|
|Aging||Drug: rapamycin||Phase 2|
The main study has completed and results are reported (NCT02874924)
Purpose of Sub-study E - Rapamycin and cMRI to evaluate cardiac function:
The over-arching hypothesis is that RAPA treatment will effect simultaneous improvement in parameters known to be negatively impacted by aging. For example, systemic inflammation is higher in older individuals and contributes to the development of age-related pathologies affecting both the heart and the vasculature. In particular, evidence indicates that aging-associated alterations in inflammatory and pro-fibrotic pathways are critically involved in the etiology of age-related declines. The study team hypothesize that mTOR antagonism with RAPA will improve detrimental age-related pathologies affecting the heart in elderly humans.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Rapamycin 1mg for 8 weeks|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly: Immune, Cognitive, and Functional Consequences ((Substudy E - RAPA cMRI With LGE)|
|Actual Study Start Date :||February 1, 2022|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||June 2024|
Rapamycin 1mg for 8 weeks
Taken orally 1mg daily for 8 weeks
Other Name: Sirolimus
- Systolic Function [ Time Frame: Baseline to 8 weeks ]Test whether RAPA improves systolic function in elderly subjects. Cardiac MRI will be measured before and after 8 weeks of RAPA administration using 3T MRI. From collected MRI data, the study team will quantify change in systolic volumes.
- Diastolic Function [ Time Frame: Baseline to 8 weeks ]Test whether RAPA improves diastolic function in elderly subjects.Cardiac MRI will be measured before and after 8 weeks of RAPA administration using 3T MRI. From collected MRI data, the study team will quantify change in diastolic volumes.
- Aortic Cross-Sectional Area [ Time Frame: Baseline to 8 weeks ]Test whether RAPA increases aortic compliance in elderly subjects. Aortic MRI will be measured before and after 8 weeks of RAPA using 3T MRI. The study team will quantify distal descending aortic cross-sectional area to assess aortic function/compliance effects.
- Aortic Distensibility [ Time Frame: Baseline to 8 weeks ]Test whether RAPA increases aortic compliance in elderly subjects. Aortic MRI will be measured before and after 8 weeks of RAPA using 3T MRI. The study team will quantify change in distal descending aortic distensibility to assess aortic function/compliance effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742777
|Contact: Dean L Kellogg, Jr., MD PhDemail@example.com|
|United States, Texas|
|Audie L. Murphy Memorial Veterans Hospital||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Dean L Kellogg, Jr., MD PhD 210-617-5197 firstname.lastname@example.org|
|Principal Investigator: Dean L Kellogg, Jr., MD PhD|
|The University of Texas Health Science Center at San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Dean Kellogg, Jr., MD|
|Principal Investigator:||Dean L Kellogg, Jr., MD PhD||The University of Texas Health Science Center at San Antonio|