This trial is !
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
Cardiac Amyloidosis or Aortic Stenosis
and you are
over 75
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
Show me locations

The purpose

Aortic stenosis (AS) is the most common valvular heart disease. Once symptomatic with severe AS, outcome is poor unless the valve is replaced surgically or via transcatheter aortic valve implantation (TAVI). Transthyretin amyloid (ATTR) deposits are common in the heart muscle in up to 25% of octogenarians, and after an asymptomatic period of unknown duration, cause overt heart failure and arrhythmias in a proportion of cases. The prevalence and impact of covert ATTR amyloidosis in elderly individuals with AS are unknown. Detection would avoid misdiagnosis, guide treatment and, potentially, improve outcomes. Recent data have shown that echocardiography, cardiovascular magnetic resonance (CMR), computed tomography (CT), and DPD scintigraphy, can identify ATTR amyloid deposits, but the clinical performance of these various tests is unknown. This study will investigate elderly patients with symptomatic severe AS using imaging to explore ATTR amyloid in AS and determine its prevalence and impact on outcome. The investigators aim to recruit a total of 250 patients aged 75 or older being considered for intervention for severe AS. The prevalence of cardiac amyloid will be assessed in three arms (sAVR, TAVI and medical therapy, with a likely patient ratio of 50:150:50), using five investigation modalities - all cohorts (echocardiography and DPD scintigraphy); sAVR cohort (biopsy and CMR); TAVI cohort (EqCT); medical therapy only cohort (as per work-up/trial prior to no intervention decision). The primary outcome measure is patient mortality. Secondary outcomes measures are major adverse cardiovascular events, length of stay, pacemaker implantation, ECV measured by EqCT and CMR. Follow up will be at 1-year with clinical echocardiogram (for sAVR and TAVI patients) and/or telephone interview for all patients (if not carried out in person at the time of the echocardiogram).

Provided treatments

  • Other: Baseline assessment
  • Procedure: Transthoracic echocardiography
  • Procedure: 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid scintigraphy
  • Radiation: CT 3-5-minute post-contrast research sequences
  • Procedure: Cardiac Magnetic Resonance
  • Procedure: Endomyocardial biopsy
  • Other: Follow-up assessment
Wondering what is the locations section for?
We will connect you to the doctor responsible for this trial and help you get more information.

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03029026. The sponsor of the trial is Queen Mary University of London and it is looking for 250 volunteers for the current phase.
Official trial title:
A sTudy invesTigating the Role of Occult cArdiaC Amyloid in The Elderly With Aortic Stenosis