Cystic FibrosisCF-VHFNCT07904325
Vascular Health and Function in Cystic Fibrosis
An observational study of Cystic Fibrosis and Endothelial Dysfunction, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Endothelial Dysfunction, Cardiovascular Risk Factor
- What is being tested?
- Non-invasive vascular, cerebrovascular and autonomic assessment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2026to 1 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 40 years or older with cystic fibrosis receiving CFTR modulator therapy, attending the adult CF outpatient clinics at Liverpool Heart and Chest Hospital (a regional centre serving Merseyside, Cheshire, Lancashire, Greater Manchester and North Wales), and healthy adults aged 40 years or older matched for sex and age, recruited from the local community including NHS and university staff and students.
Who may be able to join
- Participants with CF:
- Able to provide written informed consent
- Aged 40 years or older
- Confirmed diagnosis of cystic fibrosis based on sweat chloride testing and/or CFTR genotyping
- Currently receiving CFTR modulator treatment at a recognised therapeutic dose
- Clinically stable (no pulmonary exacerbation or hospitalisation in the previous 4 weeks)
Show all 12Show fewer
- Healthy controls:
- Able to provide written informed consent
- Aged 40 years or older
- Healthy, in sinus rhythm, with normal blood pressure (systolic below 140 mmHg and diastolic below 90 mmHg)
- No pulmonary exacerbation or hospitalisation in the previous 4 weeks
- Not taking any prescription medications (other than contraceptives and/or hormone replacement therapy)
Who cannot join
- History of stroke
- Current use of oral nitrates
- Valvular heart disease
- Acute coronary syndrome within the previous 3 months
- Previous organ transplantation
- Uncontrolled thyroid disorder
Show all 17Show fewer
- Cancer
- Current infection or pyrexia
- Long-term steroids or any vasoactive medication
- End-stage organ disease
- Inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematosus)
- Pregnancy or breastfeeding
- Current smoker or vaper, or smoked or vaped within the last 10 years
- Unable to undergo vascular assessments (e.g. upper limb vascular anomaly or limb injury)
- Unable to comply with fasting and pre-test instructions
- Clinic blood pressure of 140/90 mmHg or higher at screening
- Unable to understand written and spoken English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
About this study
Official title: Cystic Fibrosis: Implications for Vascular Health and Function
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:
Read more
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
Read the detailed description
Background: Cystic fibrosis (CF) is associated with chronic systemic inflammation, oxidative stress and several cardiometabolic risk factors. Highly effective CFTR modulator therapy has greatly increased life expectancy, and the ageing CF population may therefore be at increasing risk of cardiovascular and cerebrovascular disease. Endothelial dysfunction has been reported in CF, but its physiological mechanisms, and the effects of CF on cerebrovascular function and autonomic control, are poorly understood.
Design: Single-centre, case-control, cross-sectional observational study. 100 participants will be recruited: 50 adults with CF aged 40 years or older receiving CFTR modulator therapy, recruited consecutively from the adult CF outpatient clinics at Liverpool Heart and Chest Hospital (LHCH), and 50 healthy controls matched for sex and age (within 4 years), recruited from the community. Each participant attends one visit. No study treatment is given.
Assessments: anthropometry (height, weight, BMI, waist/hip ratio, body fat percentage); radial artery low-flow mediated constriction (L-FMC) and flow-mediated dilation (FMD) by high-resolution ultrasound after 5 minutes of wrist cuff occlusion, in line with international guidelines; bilateral common carotid intima-media thickness (IMT) and carotid artery reactivity (CAR) to a 3-minute cold pressor test; 12-lead ECG, beat-to-beat finger blood pressure and breath-by-breath O2 and CO2; bilateral transcranial Doppler of the middle and posterior cerebral arteries to assess neurovascular coupling (visual stimulation protocol), spontaneous and dynamic cerebral autoregulation and baroreflex sensitivity (10 minutes supine rest, then sit-to-stand and 5 minutes of repeated 10-second squat-stand manoeuvres); blood sampling for full blood count, renal function, HbA1c, lipid profile, and inflammatory and oxidative stress markers (e.g. CRP, CK-MB, IL-1, IL-2, IL-6, TNF-alpha, superoxide dismutase, malondialdehyde, F2-isoprostanes) measured by ELISA; cognitive testing (Standardised Mini-Mental State Examination, Wisconsin Card Sorting Task, Lexical Decision Task); Hospital Anxiety and Depression Scale; and quality of life (RAND-36, EQ-5D-5L).
Sample size: Based on an effect size (Cohen's d) of 0.59 for FMD between people with CF and healthy controls (Clayton et al., 2025), 47 participants per group are needed for a two-tailed unpaired comparison at alpha 0.05 and 80% power. 50 per group will be recruited to allow for attrition.
Analysis: The primary analysis will compare radial artery L-FMC and FMD between groups. Secondary analyses will compare carotid IMT and CAR, neurovascular coupling, cerebral autoregulation, baroreflex function, and inflammatory and oxidative stress markers. Regression analyses in the CF group will examine associations between inflammatory and oxidative stress markers and vascular and autonomic measures, and between cognitive, mood and cerebrovascular measures.
The study is sponsored by LHCH and jointly funded by LHCH and Manchester Metropolitan University as part of a PhD programme.
- Being tested
- Non-invasive vascular, cerebrovascular and autonomic assessment
- Keywords
- Flow Mediated Dilation, Low-Flow Mediated Constriction, Carotid Artery Reactivity, Neurovascular Coupling, Cerebral Autoregulation, Baroreceptor Reflex, Transcranial Doppler Ultrasonography, CFTR Modulators, Oxidative Stress
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive vascular, cerebrovascular and autonomic assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adults with cystic fibrosis | Adults aged 40 years or older with a confirmed diagnosis of cystic fibrosis, receiving CFTR modulator therapy at a recognised therapeutic dose and clinically stable (no pulmonary exacerbation or hospitalisation in the previous 4 weeks), recruited consecutively from the adult CF outpatient clinics at Liverpool Heart and Chest Hospital. Target n = 50. Participants attend a single study visit for vascular, cerebrovascular, autonomic, blood, cognitive and questionnaire assessments. Receives: Other: Non-invasive vascular, cerebrovascular and autonomic assessment | |
| Healthy controls | Healthy adults aged 40 years or older, matched to participants with CF for sex and age (within 4 years), in sinus rhythm with normal blood pressure (below 140/90 mmHg) and taking no prescription medications other than contraceptives or hormone replacement therapy. Recruited from the local community (including NHS and university staff and students) via advertisements. Target n = 50. Participants attend a single study visit at Liverpool Heart and Chest Hospital or Manchester Metropolitan University for the same assessments as the CF group. Receives: Other: Non-invasive vascular, cerebrovascular and autonomic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery flow-mediated dilation (FMD)
Percentage change in radial artery diameter
Measured: Single study visit (Day 1)
Radial artery low-flow mediated constriction (L-FMC)
Percentage change in radial artery diameter
Measured: Single study visit (Day 1)
Secondary outcomes (7)
Carotid artery reactivity (CAR)
Percentage change in common carotid artery diameter from 1 minute of rest to the peak response during 3 minutes of hand immersion in iced water (4 degrees C or below; cold pressor test), measured by high-resolution ultrasound. Compared between adults with CF and age/sex matched healthy controls.
Measured: Single study visit (Day 1)
Carotid intima-media thickness (IMT)
Mean common carotid artery intima-media thickness (mm), measured bilaterally by B-mode ultrasound approximately 1 cm proximal to the carotid bulb in anterior, lateral and posterior views. Compared between adults with CF and age/sex matched healthy controls.
Measured: Single study visit (Day 1)
Cerebral neurovascular coupling
Change in cerebral artery mean blood flow velocity (transcranial Doppler) in response to a standard visual stimulation protocol (alternating 30-second eyes open and eyes closed periods), expressed as percentage increase from eyes-closed baseline. Compared between adults with CF and age/sex matched healthy controls.
Measured: Single study visit (Day 1)
Cerebral autoregulation (spontaneous and dynamic)
Relationship between beat-to-beat blood pressure and cerebral artery mean blood flow velocity (transcranial Doppler), assessed during 10 minutes of supine rest (spontaneous) and during 5 minutes of repeated 10-second squat-stand manoeuvres (dynamic), with continuous ECG and end-tidal gas monitoring. Compared between adults with CF and age/sex matched healthy controls.
Measured: Single study visit (Day 1)
Baroreflex sensitivity and baroreflex effectiveness index
Cardiac baroreflex sensitivity (ms/mmHg) and baroreflex effectiveness index derived from continuous ECG and beat-to-beat finger blood pressure, during 10 minutes of supine rest (spontaneous) and during 5 minutes of repeated 10-second squat-stand manoeuvres (dynamic). Compared between adults with CF and age/sex matched healthy controls.
Measured: Single study visit (Day 1)
Cognitive function
Cognitive performance assessed by the Standardised Mini-Mental State Examination (total score 0 to 30; higher scores indicate better cognitive function), the Wisconsin Card Sorting Task (e.g. categories completed and perseverative errors) and a Lexical Decision Task (accuracy and reaction time). Compared between adults with CF and age/sex matched healthy controls, and examined for association with neurovascular coupling.
Measured: Single study visit (Day 1)
Anxiety and depression (Hospital Anxiety and Depression Scale)
Hospital Anxiety and Depression Scale anxiety and depression subscale scores (each 0 to 21; higher scores indicate more severe symptoms). Compared between adults with CF and age/sex matched healthy controls, and examined for association with neurovascular coupling.
Measured: Single study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Freddy Frost, Principal investigator, Liverpool Heart and Chest Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904325
- Sponsor's protocol ID
- 1748
- Other IDs
- 374010, 26/WA/0219
- Acronym
- CF-VHF
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystic Fibrosis: Implications for Vascular Health and Function
- ClinicalTrials.gov ID
- NCT07904325
- Acronym / sponsor ID
- CF-VHF / 1748
- Keywords
- Flow Mediated Dilation, Low-Flow Mediated Constriction, Carotid Artery Reactivity, Neurovascular Coupling, Cerebral Autoregulation, Baroreceptor Reflex, Transcranial Doppler Ultrasonography, CFTR Modulators
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 29 Oct 2026 (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.
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
Detailed description
Background: Cystic fibrosis (CF) is associated with chronic systemic inflammation, oxidative stress and several cardiometabolic risk factors. Highly effective CFTR modulator therapy has greatly increased life expectancy, and the ageing CF population may therefore be at increasing risk of cardiovascular and cerebrovascular disease. Endothelial dysfunction has been reported in CF, but its physiological mechanisms, and the effects of CF on cerebrovascular function and autonomic control, are poorly understood.
Design: Single-centre, case-control, cross-sectional observational study. 100 participants will be recruited: 50 adults with CF aged 40 years or older receiving CFTR modulator therapy, recruited consecutively from the adult CF outpatient clinics at Liverpool Heart and Chest Hospital (LHCH), and 50 healthy controls matched for sex and age (within 4 years), recruited from the community. Each participant attends one visit. No study treatment is given.
Assessments: anthropometry (height, weight, BMI, waist/hip ratio, body fat percentage); radial artery low-flow mediated constriction (L-FMC) and flow-mediated dilation (FMD) by high-resolution ultrasound after 5 minutes of wrist cuff occlusion, in line with international guidelines; bilateral common carotid intima-media thickness (IMT) and carotid artery reactivity (CAR) to a 3-minute cold pressor test; 12-lead ECG, beat-to-beat finger blood pressure and breath-by-breath O2 and CO2; bilateral transcranial Doppler of the middle and posterior cerebral arteries to assess neurovascular coupling (visual stimulation protocol), spontaneous and dynamic cerebral autoregulation and baroreflex sensitivity (10 minutes supine rest, then sit-to-stand and 5 minutes of repeated 10-second squat-stand manoeuvres); blood sampling for full blood count, renal function, HbA1c, lipid profile, and inflammatory and oxidative stress markers (e.g. CRP, CK-MB, IL-1, IL-2, IL-6, TNF-alpha, superoxide dismutase, malondialdehyde, F2-isoprostanes) measured by ELISA; cognitive testing (Standardised Mini-Mental State Examination, Wisconsin Card Sorting Task, Lexical Decision Task); Hospital Anxiety and Depression Scale; and quality of life (RAND-36, EQ-5D-5L).
Sample size: Based on an effect size (Cohen's d) of 0.59 for FMD between people with CF and healthy controls (Clayton et al., 2025), 47 participants per group are needed for a two-tailed unpaired comparison at alpha 0.05 and 80% power. 50 per group will be recruited to allow for attrition.
Analysis: The primary analysis will compare radial artery L-FMC and FMD between groups. Secondary analyses will compare carotid IMT and CAR, neurovascular coupling, cerebral autoregulation, baroreflex function, and inflammatory and oxidative stress markers. Regression analyses in the CF group will examine associations between inflammatory and oxidative stress markers and vascular and autonomic measures, and between cognitive, mood and cerebrovascular measures.
The study is sponsored by LHCH and jointly funded by LHCH and Manchester Metropolitan University as part of a PhD programme.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with cystic fibrosis | – | Other: Non-invasive vascular, cerebrovascular and autonomic assessmentAdults aged 40 years or older with a confirmed diagnosis of cystic fibrosis, receiving CFTR modulator therapy at a recognised therapeutic dose and clinically stable (no pulmonary exacerbation or hospitalisation in the previous 4 weeks), recruited consecutively from the adult CF outpatient clinics at Liverpool Heart and Chest Hospital. Target n = 50. Participants attend a single study visit for vascular, cerebrovascular, autonomic, blood, cognitive and questionnaire assessments. |
| Healthy controls | – | Other: Non-invasive vascular, cerebrovascular and autonomic assessmentHealthy adults aged 40 years or older, matched to participants with CF for sex and age (within 4 years), in sinus rhythm with normal blood pressure (below 140/90 mmHg) and taking no prescription medications other than contraceptives or hormone replacement therapy. Recruited from the local community (including NHS and university staff and students) via advertisements. Target n = 50. Participants attend a single study visit at Liverpool Heart and Chest Hospital or Manchester Metropolitan University for the same assessments as the CF group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40 years or older with cystic fibrosis receiving CFTR modulator therapy, attending the adult CF outpatient clinics at Liverpool Heart and Chest Hospital (a regional centre serving Merseyside, Cheshire, Lancashire, Greater Manchester and North Wales), and healthy adults aged 40 years or older matched for sex and age, recruited from the local community including NHS and university staff and students.
Key inclusion criteria (12 listed)
- Able to provide written informed consent
- Aged 40 years or older
- Confirmed diagnosis of cystic fibrosis based on sweat chloride testing and/or CFTR genotyping
- Currently receiving CFTR modulator treatment at a recognised therapeutic dose
- Clinically stable (no pulmonary exacerbation or hospitalisation in the previous 4 weeks)
Key exclusion criteria (17 listed)
- History of stroke
- Current use of oral nitrates
- Valvular heart disease
- Acute coronary syndrome within the previous 3 months
- Previous organ transplantation
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 |
|---|---|---|
| Non-invasive vascular, cerebrovascular and autonomic assessmentNo 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. | Other | Adults with cystic fibrosis, Healthy controls |
Primary outcome
Radial artery flow-mediated dilation (FMD)
Time frame: Single study visit (Day 1)
Percentage change in radial artery diameter
Radial artery low-flow mediated constriction (L-FMC)
Time frame: Single study visit (Day 1)
Percentage change in radial artery diameter
7 secondary outcomes
Carotid artery reactivity (CAR)
Time frame: Single study visit (Day 1)
Carotid intima-media thickness (IMT)
Time frame: Single study visit (Day 1)
Cerebral neurovascular coupling
Time frame: Single study visit (Day 1)
Cerebral autoregulation (spontaneous and dynamic)
Time frame: Single study visit (Day 1)
Baroreflex sensitivity and baroreflex effectiveness index
Time frame: Single study visit (Day 1)
Cognitive function
Time frame: Single study visit (Day 1)
Anxiety and depression (Hospital Anxiety and Depression Scale)
Time frame: Single study visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Freddy Frost principal investigator
Liverpool Heart and Chest Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Endothelial Dysfunction, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 12 inclusion and 17 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Freddy Frost (+44 151 600 3055, freddy.frost@lhch.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery flow-mediated dilation (FMD) (time frame: Single study visit (Day 1)). 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 29 Oct 2026.