NCT07752732 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)
| NCT ID | NCT07752732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Tuebingen |
| Condition | Amyloidosis Cardiac |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2020-01-14 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2020-01-14 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Patrick Krumm, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
University Hospital of Tuebingen
Frequently Asked Questions
Who can join the NCT07752732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyloidosis Cardiac. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07752732 currently recruiting?
Yes, NCT07752732 is actively recruiting participants. Contact the research team at patrick.krumm@med.uni-tuebingen.de for enrollment information.
Where is the NCT07752732 trial being conducted?
This trial is being conducted at Tübingen, Germany.
Who is sponsoring the NCT07752732 clinical trial?
NCT07752732 is sponsored by University Hospital Tuebingen. The principal investigator is Patrick Krumm, Prof. Dr. med. at University Hospital of Tuebingen. The trial plans to enroll 600 participants.