Detecting cardiac amyloidosis in people with severe aortic valve narrowing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study uses multimodal imaging to detect cardiac amyloidosis in adults with severe aortic valve stenosis considered for TAVI. It employs Tc-99m SPECT/CT and CT to measure amyloid-related tracer uptake and tissue characteristics, with CMR added when available. The goal is to see if these imaging biomarkers can identify amyloidosis before or during TAVI planning. Results may clarify how coexisting amyloidosis influences outcomes and management. The study is conducted at University Hospital Tübingen with collaboration from Bayer.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital of Tuebingen
  Tübingen, Germany Recruiting

Study contacts

• Principal investigator: Patrick Krumm, Prof. Dr. med. — University Hospital of Tuebingen
• Study coordinator: Patrick Krumm, Prof. Dr. med.
• Email: patrick.krumm@med.uni-tuebingen.de
• Phone: +49 7071 29 68119

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.