Clinical trial

Impact of T Cells on Age-related Vascular Dysfunction: A Translational Approach

Name
IRB_00118392
Description
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States and other industrialized societies, and advanced age is the major risk factor for development of CVD. Advancing age appears to exert its pathological influence primarily via adverse functional and structural effects on arteries. Aging is associated with increased stiffness (reduced compliance) of large elastic arteries and impaired arterial endothelial function that is characterized by reductions in nitric oxide (NO)- mediated endothelium-dependent dilation (EDD). While several changes to arteries may contribute to age-associated increases in CVD risk; the development of endothelial dysfunction and stiffening of the large elastic arteries are among the most important contributors. Both are predictors of CV events and clinical CVD with increasing age. Although the importance of endothelial dysfunction and arterial stiffening with age are well established, the initiating events of these deleterious changes are elusive.
Trial arms
Trial start
2024-08-01
Estimated PCD
2025-08-01
Trial end
2025-08-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Placebo
Placebo injection at day one and day fourteen.
Arms:
Older Adult participants
Abatacept 10 mg/kg
Abatacept injection at day twenty eight and day forty two.
Arms:
Older Adult participants
Size
20
Primary endpoint
Change in brachial arterial diameter after abatacept injection.
7 weeks
Change in brachial arterial flow rate after abatacept injection.
7 weeks
Eligibility criteria
Inclusion Criteria: * Older adults (55-75 years old). * Women will be at least two years postmenopausal, not using hormone therapy and have a follicle stimulating hormone (FSH) concentration of \>30 IU/L. Exclusion Criteria: * Autoimmune disorders, * Hypertension (blood pressure \>140/90mmHg), * Body mass index of \>30 kg/m2, * Clinical CVD, * Diabetes * Current tobacco use, * Regular aerobic exercise (\>30 mins per day, \> 2 days per week for the at least the last 2 years), * Current or recurring infections within 12 weeks of the baseline visit, * A positive tuberculosis (TB) test or subjects at risk of TB, * Positive test for Hepatitis B, C, or cytomegalovirus (CMV), * Use of immunosuppressive medication, * Vaccination within 4 weeks of the baseline visit, * Major surgery within 8 weeks of the baseline visit, * Previous lymphoid irradiation or bone marrow transplant, * Subjects at risk for diverticulitis, * Any laboratory test result that, in the opinion of the overseeing physician (Dr. Frech) might place a participant at unacceptable risk.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective placebo controlled crossover design', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-05-16

1 organization

1 product

3 indications

Organization
University of Utah
Product
Abatacept
Indication
Inflammation
Indication
Aging