NCT06047561

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
May 2023May 2028

Study Start

First participant enrolled

May 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2028

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

August 18, 2023

Last Update Submit

September 16, 2025

Conditions

Aortic Stenosis

Keywords

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Haemodynamic aortic valve disease progression.

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

    4 years

Secondary Outcomes (1)

  • Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression.

    4 years

Study Arms (3)

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

PET-CTRADIATION

PET combined with CT or MRI

Also known as: Positron Emission Tomography
Aortic StenosisAortic Valve ReplacementHealthy Volunteers

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Neil Craig

CONTACT

07383558066neil.craig@ed.ac.uk

David Newby

CONTACT

d.e.newby@ed.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 21, 2023

Study Start

May 22, 2023

Primary Completion (Estimated)

May 22, 2028

Study Completion (Estimated)

May 22, 2028

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
End of Study to 15 years

Locations

GB(1)