About this trial
Degenerative aortic stenosis (AS) is frequently accompanied by left ventricular hypertrophy and diastolic dysfunction, features that overlap with transthyretin (ATTR) cardiac amyloidosis. Because concomitant cardiac amyloidosis may adversely affect outcomes after transcatheter aortic valve implantation (TAVI), its early detection is clinically important.
This prospective observational study aims to evaluate multimodal imaging biomarkers for the detection and characterization of cardiac amyloidosis in patients with severe AS undergoing TAVI evaluation. Clinically indicated technetium-99m phosphonate SPECT/CT and CT will be used to assess the presence and extent of cardiac amyloidosis, including quantitative measures of myocardial tracer uptake and extracellular volume. In patients with abnormal findings, cardiac magnetic resonance imaging (CMR) will be performed as an additional non-invasive imaging modality according to institutional clinical practice.
The study will determine the prevalence of cardiac amyloidosis in this population and investigate the diagnostic and prognostic value of imaging-derived quantitative parameters. Standardized clinical follow-up at 6, 12, and 24 months will assess associations between imaging biomarkers and clinical outcomes. The study is observational and does not alter routine clinical management or diagnostic pathways.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with severe aortic valve stenosis (valve opening area <1 cm², pmean >40 mmHg, Vmax >4 m/sec)
Suspected cardiac amyloidosis
Performance of one or more of the following imaging examinations due to (justifiable) clinical indication: echocardiography, photon-counting computed tomography (CT), Tc99-SPECT/CT, cardiac MRI
Age ≥18 years
Disqualifiers
None
Trial population
Cardiac Patients of the University Hospital of Tuebingen
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of Participants Diagnosed with Cardiac Amyloidosis
Presence of cardiac amyloidosis as determined by the study imaging protocol and diagnostic criteria. The prevalence will be reported as the proportion of participants diagnosed with cardiac amyloidosis among patients with severe aortic valve stenosis.
Secondary outcomes
Number of Participants Experiencing Adverse Cardiac Events
Occurrence of major adverse cardiovascular events during follow-up. The prognostic value of the imaging examinations will be assessed.
Sponsors and contacts
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University Hospital Tuebingen
Lead sponsor
Bayer
Collaborator