Non-Interventional Study on the Prevalence of Cardiac Amyloidosis in Patients With Higher-Grade Aortic Valve Stenosis - Evaluation Using Echocardiography, Computed Tomography, Tc99-SPECT/CT and Cardiac Magnetic Resonance Imaging (CMR)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Patients with higher grade aortic stenosis

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline

Secondary outcomes

1

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.

Time frame
Up to 2 years after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.