Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

University of Utah

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Cardiovascular Diseases

Inflammation

Eligibility:

All Genders

55-75 years

Phase:

EARLY_PHASE1

Brief Summary

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. ...

Detailed Description

Advanced age is the primary and most predictive risk factor for CVD. The investigators have demonstrated that there is a pronounced age-associated increase in T cell infiltration into the perivascular...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04344873

Start Date

September 1 2025

End Date

November 1 2026

Last Update

April 3 2025

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