Aortic StenosisSALTIRENCT06047561
The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
An observational study of Aortic Stenosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- PET-CT
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2023to 22 May 2028
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit up to 300 patients with aortic valve disease across the spectrum of disease severities from aortic sclerosis through to mild, moderate and severe aortic stenosis as defined by the European Society of Cardiology. We will also include those who have undergone bioprosthetic aortic valve replacement, and age and sex-matched control subjects with normal aortic valves.
Who may be able to join
- Male or female aged >50 years
- Provision of informed consent prior to any study specific procedures
- Patients with bioprosthetic aortic valve replacements, including both surgically and transcatheter implanted valves
- Patients with severe aortic stenosis (peak velocity >4.0 m/s; previously recruited patients)
- Patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s; new prospectively recruited patients)
- Patients with mild aortic stenosis (peak velocity 2.5-2.9 m/s; new prospectively recruited patients)
- Patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow)
- Age and sex-matched healthy volunteers
Who cannot join
- Inability or unwilling to give informed consent.
- Those with an allergy to iodinated contrast
- Patients with impaired renal function (eGFR of <30 mL/min/1.73m2)
- Women who are pregnant or breastfeeding.
- Patients with known Rheumatic Heart Disease
- Patients with known Ochronosis
- Patients with known Familial Homozygous Hypercholesterolaemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Newby contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Edinburgh
Edinburgh, EH16 4SB
Neil Craig, 07383558066, neil.craig@ed.ac.uk
Neil Craig
About this study
The goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement.
Participants will undergo transthoracic echocardiography every 6 months, with annual visits for state-of-the-art scanning techniques including positron-emission tomography combined with computed tomography or magnetic resonance imaging with radiotracers designed to look at disease processes including fibrosis, calcification, inflammation and thrombosis activity.
Read the detailed description
This will be an observational cohort study using existing and prospectively recruited cohorts for both cross-sectional and longitudinal comparison across the spectrum of aortic stenosis severity. For existing cohorts of patients who have previously undergone research assessments, we will invite them for repeated assessments.
Participants will be reviewed every 6 months in the Clinical Research Facility (CRF) over a 4-year period. They will undergo clinical assessment, blood sampling, transthoracic echocardiography and advanced imaging annually including CT angiography, magnetic resonance and positron emission tomography (PET).
- Conditions
- Aortic Stenosis
- Being tested
- PET-CT
- Keywords
- Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTRadiation
Also called Positron Emission Tomography
PET combined with CT or MRI
| Study group | Role | What they receive |
|---|---|---|
| Aortic Stenosis | Participants with Aortic Stenosis across the spectrum of disease severity Receives: Radiation: PET-CT | |
| Aortic Valve Replacement | Participants who have previously undergone aortic valve replacement Receives: Radiation: PET-CT | |
| Healthy Volunteers | Healthy Volunteers for the purposes of case-control analysis Receives: Radiation: PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic aortic valve disease progression.
Rate of change of maximal aortic valve jet velocity (AV Vmax)
Measured: 4 years
Secondary outcomes (1)
Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression.
Rate of change of tissue-to-background ratio (TBRmax) of FDG, GP1, FAPI and NaF PET.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 May 2023
- Primary completion22 May 2028 (estimated)
- Study completion22 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047561
- Sponsor's protocol ID
- AC22131
- Other IDs
- RG/F/22/110093
- Acronym
- SALTIRE
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
- ClinicalTrials.gov ID
- NCT06047561
- Acronym / sponsor ID
- SALTIRE / AC22131
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 22 May 2028 (estimated)
- Study completion
- 22 May 2028 (estimated)
- First posted
- 21 Sep 2023 (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 understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement.
Participants will undergo transthoracic echocardiography every 6 months, with annual visits for state-of-the-art scanning techniques including positron-emission tomography combined with computed tomography or magnetic resonance imaging with radiotracers designed to look at disease processes including fibrosis, calcification, inflammation and thrombosis activity.
Detailed description
This will be an observational cohort study using existing and prospectively recruited cohorts for both cross-sectional and longitudinal comparison across the spectrum of aortic stenosis severity. For existing cohorts of patients who have previously undergone research assessments, we will invite them for repeated assessments.
Participants will be reviewed every 6 months in the Clinical Research Facility (CRF) over a 4-year period. They will undergo clinical assessment, blood sampling, transthoracic echocardiography and advanced imaging annually including CT angiography, magnetic resonance and positron emission tomography (PET).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aortic Stenosis | – | Radiation: PET-CTParticipants with Aortic Stenosis across the spectrum of disease severity |
| Aortic Valve Replacement | – | Radiation: PET-CTParticipants who have previously undergone aortic valve replacement |
| Healthy Volunteers | – | Radiation: PET-CTHealthy Volunteers for the purposes of case-control analysis |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit up to 300 patients with aortic valve disease across the spectrum of disease severities from aortic sclerosis through to mild, moderate and severe aortic stenosis as defined by the European Society of Cardiology. We will also include those who have undergone bioprosthetic aortic valve replacement, and age and sex-matched control subjects with normal aortic valves.
Key inclusion criteria (8 listed)
- Male or female aged >50 years
- Provision of informed consent prior to any study specific procedures
- Patients with bioprosthetic aortic valve replacements, including both surgically and transcatheter implanted valves
- Patients with severe aortic stenosis (peak velocity >4.0 m/s; previously recruited patients)
- Patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s; new prospectively recruited patients)
Key exclusion criteria (7 listed)
- Inability or unwilling to give informed consent.
- Those with an allergy to iodinated contrast
- Patients with impaired renal function (eGFR of <30 mL/min/1.73m2)
- Women who are pregnant or breastfeeding.
- Patients with known Rheumatic Heart Disease
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 |
|---|---|---|
| PET-CTAlso: Positron Emission TomographyPET combined with CT or MRI | Radiation | Aortic Stenosis, Aortic Valve Replacement, Healthy Volunteers |
Primary outcome
Haemodynamic aortic valve disease progression.
Time frame: 4 years
Rate of change of maximal aortic valve jet velocity (AV Vmax)
1 secondary outcome
Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression.
Time frame: 4 years
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
David Newby contact
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 Aortic Stenosis, run by University of Edinburgh 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Sep 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 Neil Craig (07383558066, neil.craig@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic aortic valve disease progression. (time frame: 4 years). 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 21 Sep 2026.