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Study identifier: NCT07752732 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingNIS-TAVI-AMY

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)

Condition: Amyloidosis Cardiac · Stenosis Coronary · TAVI(Transcatheter Aortic Valve Implantation)  ·  Sponsor: University Hospital Tuebingen

PhaseN/A
Planned participants600
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
WhereTübingen, Germany

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Patrick Krumm, Prof. Dr. med.  ·  +49 7071 29 68119  ·  patrick.krumm@med.uni-tuebingen.de

Studienzentrum Bildgebung Radiology  ·  +49 7071 29 85251  ·  studienzentrum-radiologie@med.uni-tuebingen.de

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * 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 * Written consent of the patient for prospective data collection regarding Tc99-SPECT/CT, CT, and, if applicable, CMR and follow-up Exclusion Criteria: • patients unable to give consent

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

University Hospital of TuebingenTübingen, GermanyRecruiting

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Tübingen

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