Cardiovascular DiseasesEarly Phase 1NCT04344873
Impact of T Cells on Age-related Vascular Dysfunction: A Translational Approach
A Early Phase 1 study testing Abatacept 10 mg/kg in people with Cardiovascular Diseases and Inflammation, run by University of Utah.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Inflammation, Aging
- What is being tested?
- Abatacept 10 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Autoimmune disorders,
- Hypertension (blood pressure >140/90mmHg),
- Body mass index of >30 kg/m2,
- Clinical CVD,
- Diabetes
- Current tobacco use,
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- 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.
About this study
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.
Read the 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 space around large elastic arteries and small resistance arteries. The objective of this study is to determine if and how T cells contribute to age-related arterial inflammation and dysfunction.
Although there is evidence from rodent studies that T cells play a critical role in arterial dysfunction, it is unknown whether this occurs in humans. Abatacept, a T cell co-stimulation inhibitor, is FDA approved for treatment of rheumatoid arthritis. Importantly, Abatacept decreases the inflammatory phenotype of circulating T cells. Abatacept will be used in older adults to be the first to determine if T cell inflammation contributes to arterial dysfunction in older adults. The investigators hypothesize that older adults treated with Abatacept will exhibit greater flow-mediated dilation, decreased pulse wave velocity, decreased or unchanged blood pressure, decreased inflammatory and oxidative stress markers in endothelial cells, decreased plasma free radicals, decreased proportion of memory T cells, and experience a shift away from a pro-inflammatory T cell phenotype compared to placebo. These results will be interpreted to mean that T cells play a role in mediating age-related arterial dysfunction in humans.
- Conditions
- Cardiovascular Diseases, Inflammation, Aging
- Being tested
- Placebo, Abatacept 10 mg/kg
- Keywords
- Aging, Inflammation, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo injection at day one and day fourteen.
Abatacept 10 mg/kgDrug
Abatacept injection at day twenty eight and day forty two.
| Study group | Role | What they receive |
|---|---|---|
| Older Adult participants | Experimental | Older adult participants (ages 55-75) will be assessed for arterial function using FMD analysis, PWV calculations, T Cell phenotyping, and proportion of inflammatory biomarkers after injections of placebo and abatacept. Receives: Other: Placebo; Drug: Abatacept 10 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brachial arterial diameter after abatacept injection.
Measured: 7 weeks
Change in brachial arterial flow rate after abatacept injection.
Measured: 7 weeks
Secondary outcomes (8)
Change in pulse wave velocity as measured by doppler ultrasound after abatacept injection.
Measured: 7 weeks
Change in proportion of memory T-Cells after abatacept injection
Measured: 7 weeks
Change in proportion of inflammatory biomarker Tumour Necrosis Factor alpha (TNF-α) after abatacept injection
Measured: 7 weeks
Change in proportion of inflammatory biomarker Interferon gamma (IFN-γ) after abatacept injection
Measured: 7 weeks
Change in proportion of inflammatory biomarker interleukin 10 (IL-10) after abatacept injection
Measured: 7 weeks
Change in proportion of inflammatory biomarker interleukin 17 (IL-17) after abatacept injection
Measured: 7 weeks
Change in proportion of inflammatory biomarker forkhead box P3 (FoxP3) after abatacept injection
Measured: 7 weeks
Change in proportion of inflammatory biomarker perforin after abatacept injection
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Sep 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Why it stopped: COVID initially delayed plans to begin recruitment of subjects. Subsequently, the departure of a clinical investigator and loss of access to equipment and study subject population resulted in study termination before any subjects were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective placebo controlled crossover design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Anthony (Tony) Donato, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344873
- Sponsor's protocol ID
- IRB_00118392
- Other IDs
- R01AG060395
- Status last verified
- Mar 2025
- First submitted
- 9 Apr 2020
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of T Cells on Age-related Vascular Dysfunction: A Translational Approach
- ClinicalTrials.gov ID
- NCT04344873
- Acronym / sponsor ID
- IRB_00118392
- Conditions
- Cardiovascular Diseases, Inflammation, Aging
- Keywords
- Aging, Inflammation, Cardiovascular disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID initially delayed plans to begin recruitment of subjects. Subsequently, the departure of a clinical investigator and loss of access to equipment and study subject population resulted in study termination before any subjects were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 space around large elastic arteries and small resistance arteries. The objective of this study is to determine if and how T cells contribute to age-related arterial inflammation and dysfunction.
Although there is evidence from rodent studies that T cells play a critical role in arterial dysfunction, it is unknown whether this occurs in humans. Abatacept, a T cell co-stimulation inhibitor, is FDA approved for treatment of rheumatoid arthritis. Importantly, Abatacept decreases the inflammatory phenotype of circulating T cells. Abatacept will be used in older adults to be the first to determine if T cell inflammation contributes to arterial dysfunction in older adults. The investigators hypothesize that older adults treated with Abatacept will exhibit greater flow-mediated dilation, decreased pulse wave velocity, decreased or unchanged blood pressure, decreased inflammatory and oxidative stress markers in endothelial cells, decreased plasma free radicals, decreased proportion of memory T cells, and experience a shift away from a pro-inflammatory T cell phenotype compared to placebo. These results will be interpreted to mean that T cells play a role in mediating age-related arterial dysfunction in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective placebo controlled crossover design
| Arm | Type | Receives |
|---|---|---|
| Older Adult participants | Experimental | Other: Placebo, Drug: Abatacept 10 mg/kgOlder adult participants (ages 55-75) will be assessed for arterial function using FMD analysis, PWV calculations, T Cell phenotyping, and proportion of inflammatory biomarkers after injections of placebo and abatacept. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- Autoimmune disorders,
- Hypertension (blood pressure >140/90mmHg),
- Body mass index of >30 kg/m2,
- Clinical CVD,
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo injection at day one and day fourteen. | Other | Older Adult participants |
| Abatacept 10 mg/kgAbatacept injection at day twenty eight and day forty two. | Drug | Older Adult participants |
Primary outcome
Change in brachial arterial diameter after abatacept injection.
Time frame: 7 weeks
Change in brachial arterial flow rate after abatacept injection.
Time frame: 7 weeks
8 secondary outcomes
Change in pulse wave velocity as measured by doppler ultrasound after abatacept injection.
Time frame: 7 weeks
Change in proportion of memory T-Cells after abatacept injection
Time frame: 7 weeks
Change in proportion of inflammatory biomarker Tumour Necrosis Factor alpha (TNF-α) after abatacept injection
Time frame: 7 weeks
Change in proportion of inflammatory biomarker Interferon gamma (IFN-γ) after abatacept injection
Time frame: 7 weeks
Change in proportion of inflammatory biomarker interleukin 10 (IL-10) after abatacept injection
Time frame: 7 weeks
Change in proportion of inflammatory biomarker interleukin 17 (IL-17) after abatacept injection
Time frame: 7 weeks
Change in proportion of inflammatory biomarker forkhead box P3 (FoxP3) after abatacept injection
Time frame: 7 weeks
Change in proportion of inflammatory biomarker perforin after abatacept injection
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Abatacept 10 mg/kg in people with Cardiovascular Diseases and Inflammation, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brachial arterial diameter after abatacept injection. (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.