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NCT07904325

Vascular Health and Function in Cystic Fibrosis

Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn whether blood vessel health and function differ between adults aged 40 years or older with cystic fibrosis (CF) who are taking CFTR modulator therapy and healthy adults of the same age and sex. As people with CF now live longer, they may face a higher risk of heart and blood vessel disease and stroke. The main question it aims to answer is: Is the function of the arteries in the arm (measured by radial artery flow-mediated dilation and low-flow mediated constriction) reduced in people with CF compared with healthy controls? Researchers will also compare the function of the neck (carotid) arteries, blood flow control in the brain, the reflexes that control blood pressure, and blood markers of inflammation and oxidative stress between the two groups. They will also look at whether these measures relate to memory and thinking, mood, and quality of life. Participants will attend a single study visit of about 2.5 to 3 hours at Liverpool Heart and Chest Hospital (or Manchester Metropolitan University for some healthy controls). During the visit they will: * Have height, weight, waist and hip size and body fat measured * Give a blood sample * Have ultrasound scans of the arm and neck arteries, including a short period with a blood pressure cuff inflated on the wrist and a few minutes with one hand in cold water * Have brain blood flow, heart rhythm, blood pressure and breathing monitored while resting, lying, standing, doing repeated squats and opening and closing their eyes * Complete short tests of memory and thinking, and questionnaires about mood and quality of life

Official title: Cystic Fibrosis: Implications for Vascular Health and Function

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-10-10

Completion Date

2030-07-01

Last Updated

2026-10-29

Healthy Volunteers

Yes

Interventions

OTHER

Non-invasive vascular, cerebrovascular and autonomic assessment

No treatment is given. At a single visit of about 2.5 to 3 hours, participants undergo anthropometry; radial artery low-flow mediated constriction and flow-mediated dilation by ultrasound; carotid intima-media thickness and carotid artery reactivity to a cold pressor test; 12-lead ECG, beat-to-beat blood pressure and breath-by-breath gas monitoring; transcranial Doppler assessment of neurovascular coupling, cerebral autoregulation and baroreflex sensitivity (supine rest, sit-to-stand and squat-stand manoeuvres); venous blood sampling; cognitive testing; and anxiety, depression and quality of life questionnaires.

Locations (1)

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom