ClinicalTrials.gg
RecruitingNCT06047561SALTIREUpdated Sep 21, 2026

The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme

An observational study in Aortic Stenosis, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University of Edinburgh · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 107 studies in Aortic Valve Stenosis with a site in United Kingdom — 20 open to participants now, 34 under way, 2 of them phase 3. Aortic Valve Stenosis · United Kingdom.

Planned enrollment
27th of 61
300 · median 252
Started
2023
with 4 others
Observational
61 of 107
9 open now
Primary completion
2028-05
later than 29 of 33 live
Registered
95th of 107
by date
Lead sponsor
9 of 107
University of Edinburgh

Among the 107 studies in Aortic Valve Stenosis with a site in United Kingdom, this one is the 27th largest by planned enrollment of the 61 observational ones that give a count, is one of 5 that started in 2023, is one of 61 observational ones, reaches primary completion later than 29 of the 33 other live ones, and was the 95th registered.

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Open to participants now

20 of the 107 studies in Aortic Valve Stenosis with a site in United Kingdom are open now.

All 20 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.

This study: 50 Years and older · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 107 studies in Aortic Valve Stenosis with a site in United Kingdom, or all of them as a file.
02

Study 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.

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).

03

Conditions studied

  • Aortic Stenosis

Keywords

  • Aortic Stenosis
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female aged >50 years
  • Provision of 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

Exclusion criteria

Exclusion Criteria:

  • Inability or unwilling to give .
  • Those with an allergy to iodinated contrast
  • Patients with impaired renal function ( 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Aortic Stenosis

    Participants with Aortic Stenosis across the spectrum of disease severity

    Radiation: PET-CT

  • Aortic Valve Replacement

    Participants who have previously undergone aortic valve replacement

    Radiation: PET-CT

  • Healthy Volunteers

    Healthy Volunteers for the purposes of case-control analysis

    Radiation: PET-CT

Interventions

  • RadiationPET-CT

    PET combined with CT or MRI

    Also known as: Positron Emission Tomography

06

What researchers measure

Primary outcomes

  1. Haemodynamic aortic valve disease progression.

    Rate of change of maximal aortic valve jet velocity (AV Vmax)

    Time frame: 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.

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: End of Study to 15 years

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for May 2028, 60 months after the start.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 60 months is above that.

Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2023
First posted
Sep 21, 2023
StartActual
May 22, 2023
Primary completionEst.
May 22, 2028
CompletionEst.
May 22, 2028
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06047561
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
May 22, 2023
Primary completion
May 22, 2028 (estimated)
Completion
May 22, 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

Neil Craig
Contact
neil.craig@ed.ac.uk
07383558066
David Newby
Contact
d.e.newby@ed.ac.uk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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