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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)

NCT07752732 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-08-07

No results posted yet for this study

Summary

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.

Conditions

  • Amyloidosis Cardiac
  • Stenosis Coronary
  • TAVI(Transcatheter Aortic Valve Implantation)

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Patrick Krumm, Prof. Dr. med. · University Hospital of Tuebingen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07752732 on ClinicalTrials.gov