Understanding Aortic Stenosis Progression and Treatment Outcomes
The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
University of Edinburgh · NCT06047561
This study looks at how aortic stenosis changes over time and how well treatments work, especially after valve replacement, by regularly checking patients' hearts and gathering health information for four years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh (other) |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT06047561 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the causes and progression of aortic stenosis, particularly following aortic valve replacement. Participants will undergo regular echocardiography every six months and annual advanced imaging techniques, such as PET-CT and MRI, to assess disease processes like fibrosis and inflammation. The study will utilize both existing and newly recruited cohorts to compare various stages of aortic stenosis severity over a four-year period. Clinical assessments and blood sampling will also be conducted to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates include individuals over 50 years old with varying severities of aortic stenosis or those with bioprosthetic aortic valve replacements.
Not a fit: Patients with severe renal impairment, known rheumatic heart disease, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of aortic stenosis, potentially enhancing patient outcomes post-treatment.
How similar studies have performed: Other studies have shown promise in understanding aortic stenosis through advanced imaging techniques, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Edinburgh
- University of Edinburgh — Edinburgh, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Neil Craig
- Email: neil.craig@ed.ac.uk
- Phone: 07383558066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Stenosis