An observational study in Aortic Stenosis and Transthyretin Amyloidosis, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by University of Edinburgh · Observational
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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.
Among the 107 studies in Aortic Valve Stenosis with a site in United Kingdom, this one is the 56th largest by enrollment of the 61 observational ones that give a count, is one of 8 that started in 2017, is one of 61 observational ones, and was the 56th registered.
1,026 studies on the registry are indexed under Aortic Valve Stenosis; 294 are open to participants now.
Browse Aortic Valve Stenosis studies →20 of the 107 studies in Aortic Valve Stenosis with a site in United Kingdom are open now. Recruiting first, the newest first:
Ceric Sàrl · Sites in United Kingdom, Austria, Estonia and 11 more countries
Ages 65–75
Novartis Pharmaceuticals · Sites in United Kingdom, United States, Austria and 8 more countries
Ages 2–11
Novartis Pharmaceuticals · Sites in United Kingdom, United States, Argentina and 20 more countries
Ages 6–11
Imperial College London · Sites in United Kingdom
Ages 18+
Sahajanand Medical Technologies Limited · Sites in United Kingdom
Ages 18–99
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 →
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: 70 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
107 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 4 · Phase 3 5
First in 2006; this study’s year is marked. 8 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 200 across 436 observational studies indexed under Aortic Valve Stenosis.
Median enrollment 215 across the 46 interventional studies, 252 across the 61 observational. Of the 66 that completed or were terminated, 22 (33%) have results posted.
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57 of 107 have an industry lead sponsor. The 10 most frequent:
University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
University of Edinburgh has 9 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
6 of the studies in Aortic Valve Stenosis with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06596460Barts & The London NHS TrustA Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI) | 2026-12-12 |
| NCT05932615Abbott Medical DevicesENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation | 2027-04 |
| NCT06008080Abbott Medical DevicesPost-Market Clinical Follow Up Study With Navitor Valve | 2027-07 |
| NCT06602609Imperial College LondonRemote Cardiovascular Monitoring in Post-TAVI Patients | 2027-07-01 |
| NCT06507579Sahajanand Medical Technologies LimitedHydra Registry - UK | 2027-07-11 |
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Among the 107 studies in Aortic Valve Stenosis with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Aortic stenosis is the most common valve disease requiring surgery in the Western world. It is defined by progressive calcification and fibrosis of the valve leaflets and restricted valve opening. This in turn exposes the heart muscle (left ventricle) to increasing pressure leading to heart muscle thickening (left ventricular hypertrophy, LVH) to normalise wall stress and maintain heart output (stroke volume). The only treatment available is relief of pressure overload by surgical or minimally invasive valve replacement (TAVI).
Transthyretin (TTR) amyloidosis is a condition characterised by deposition of insoluble transthyretin protein (a small protein tetramer produced in the liver) in various tissues, predominantly in the heart. Although there are inherited forms caused by specific TTR gene mutations, most cases occur in older individuals with non-mutated TTR (wild-type). The finding of TTR plaques in elderly individuals is relatively common; in a post-mortem study 22-25% of patients over the age of 80 had evidence of cardiac amyloid deposition. However, there is significant progressive amyloid accumulation in a small percentage of individuals leading to heart muscle thickening and heart failure. No medical treatments are currently licensed although several agents are at advanced stages of clinical trials.
As both the above conditions are increasingly common in the elderly population and characterised by increased heart muscle thickening, there is the potential for them to coexist unrecognised in individual patients. The prevalence of cardiac amyloidosis in clinical populations with significant aortic stenosis is not known however small series have estimated somewhere in the region of 6-29%. Other data have suggested that patients with aortic stenosis and concurrent cardiac amyloidosis have an adverse prognosis even despite AVR. It is therefore important to identify aortic stenosis patients with coexistent amyloidosis both in terms of predicting prognosis and because it may influence decisions about whether to proceed to valve intervention.
PET/MR is an emerging technique, which combines the excellent temporal and spatial resolution of MRI with the sensitive molecular imaging of PET. PET/MR has significant advantages over PET/CT (the currently more widely used approach) in that it offers superior tissue characterisation, improved correction for cardiac and respiratory motion and major reductions in radiation exposure. Whilst there are concerns about its ability to provide reliable attenuation correction of the PET data, these issues appear to have been largely overcome with recent techniques proposed by our group. MR is also more naturally suited to the imaging of certain tissues in the body compared to CT including the left ventricular myocardium.
In aortic stenosis, MRI has become the gold-standard technique for examining the heart muscle (myocardium) with the unique ability to assess its tissue composition. In particular both late gadolinium enhancement (LGE) and T1 mapping based techniques are able to detect heart scarring (fibrosis) which act as biomarkers of left ventricular decompensation and are strongly associated with poor patient outcomes. CMR is also the gold-standard non-invasive technique for detecting cardiac amyloid, which is associated with both a characteristic pattern of LGE and high native T1 values. However it is not currently able to differentiate between the two different types of cardiac amyloid TTR and AL amyloidosis, which have different prognoses and treatments. Preliminary studies conducted by our group have suggested that 18F-NaF PET when added to CMR can make this distinction on the basis that this tracer binds to TTR deposits but not AL deposits, may be able to differentiate between the two. Importantly we have also used the same PET tracer as a marker of calcification activity in the aortic valve, demonstrating its ability to predict disease progression and cardiac events.
In this study, we will investigate whether PET/MR could be used as "one-stop" imaging in aortic stenosis in whom valve intervention is being considered to assess in detail functional and structural properties of both the valve and myocardium and identify cases of significant cardiac TTR amyloid deposition.
AS group: patients at NHS Lothian referred for aortic valve intervention
Healthy volunteer group: healthy volunteers from South-East Scotland who meet the inclusion criteria
Inclusion Criteria (AS group)
Exclusion Criteria (AS group)
Inclusion Criteria (Healthy volunteers)
Exclusion Criteria (Healthy volunteers)
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.
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 authorized 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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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 authorized 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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with severe aortic stenosis \>70 years of age referred for aortic valve intervention
Patients with no history of symptoms to suggest current cardiovascular disease \>70 years of age
PET signal intensity quantified by calculation of standard uptake values
Time frame: Pre surgery scan
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Aug 2018, 9 months.
Of 206 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 9 months is below that.
Counting every sponsor, half of 243 studies reached it within 44 months; a quarter within 23 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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