ClinicalTrials.gov record 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)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

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)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationGermany
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational cohort study looks for cardiac amyloidosis in patients with higher-grade aortic valve stenosis evaluated for TAVI. It uses clinically indicated imaging—echocardiography, photon-counting CT, Tc99-SPECT/CT—and adds cardiac MRI (CMR) when SPECT/CT findings are abnormal. The study will determine how common cardiac amyloidosis is in this group and follow participants at 6, 12, and 24 months to explore links between imaging findings and clinical outcomes. The study does not change routine clinical care.

What it is studying. The study tests multimodal imaging biomarkers (echocardiography, CT, Tc99-SPECT/CT, and CMR) to detect and characterize cardiac amyloidosis, to quantify myocardial tracer uptake, and to assess the diagnostic and prognostic value of these imaging measures.

What the researchers hope to learn. Determine the prevalence of cardiac amyloidosis in patients with severe aortic valve stenosis; develop and quantify imaging-derived parameters (including myocardial tracer uptake) for detection and characterization of cardiac amyloidosis; and investigate associations between imaging biomarkers and clinical outcomes over a two-year follow-up.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Degenerative aortic valve stenosis (AS) is currently the most common heart valve disease in western countries. It is defined as aortic valve opening area <1.0cm² and/or an average gradient of 40mmHg. Elderly patients with higher-grade AS are primarily treated interventionally by means of transcatheter aortic valve implantation (TAVI). The outcome here does not seem to be any worse compared to conventional/cardiac aortic valve replacement. A hallmark of higher grade AS is left ventricular hypertrophy. In addition, there is often a restrictive filling pattern, which can be demonstrated in echocardiography. These characteristics are also found in cardiac amyloidosis of the TTR type (transthyretin type). Amyloid was found in over 70% of surgically removed heart valves in patients who received an aortic valve replacement. The detection of amyloid is of clinical importance for the patient, since there are different therapeutic approaches depending on the respective amyloid form. Endomyocardial biopsy (EMB) is currently the gold standard for the detection of cardiac amyloidosis in many places. However, it is an invasive procedure with associated risks and limitations (e.g. sampling error). Cardiac amyloidosis can be recognized non-invasively by the calcium-associated storage of technetium 99m (Tc99m)-labelled phosphonates, as is traditionally used in skeletal scintigraphy. According to the previous data, Tc99m phosphonate scintigraphy using SPECT/CT has a high specificity for the detection of TTR amyloidosis. If a SPECT/CT is available, this non-invasive diagnostic procedure is preferred to EMB. The previous data indicate a correlation between the prognosis and the phosphonate storage in the myocardium. Using the Perugini score, the tracer uptake is only classified as a discrete size in a rough grid. A quantification of myocardial radiopharmaceutical intake could provide quantitative parameters that not only better reflect the severity of cardiac amyloidosis, but could also serve as a prognostic parameter. Such a quantification could take place through hybrid imaging using SPECT/CT, in which the anatomical information from computer tomography (CT) is combined with the functional information from single photon emission tomography (SPECT). This quantification takes place in a post-processing of the acquired data sets. In addition to Tc99-SPECT/CT, cardiac MRI (CMR) with its excellent tissue characterization can also display inflammatory and fibrotic changes in the heart muscle, as can occur in amyloidosis as part of protein deposition. In addition to the established late gadolinium enhancement (LGE) technique, which can primarily map focal fibrotic processes with high accuracy, current CMR techniques for tissue characterization (T1/T2 mapping) can also be used to quantify diffuse myocardial changes, and distinguish fibrotic from inflammatory changes of the heart muscle by T1 or T2 weighting. If the Tc99-SPECT/CT findings are noticeable, a subsequent CMR is carried out for verification at the UKT as standard. This is the case in approximately 10% of patients. If early detection of cardiac amyloidosis is assured, the clinical course of the patient could possibly be positively influenced by timely adequate therapy. The aim of this study is to first determine the prevalence of cardiac amyloidosis using SPECT/CT and, if available, to quantify it. In patients with conspicuous SPECT/CT, the multimodal CMR is then (still) more likely to make possible cardiac amyloidosis as a second non-invasive method. The standardized follow-up after 6 or 12/24 months is planned to check the parameters determined by imaging technology (Tc99-SPECT/CT (or CMR)) for their prognostic relevance.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will be asked to give written consent so the study team can collect your clinical and imaging data. Participation involves imaging tests done for clinical reasons: echocardiography, photon-counting computed tomography (CT), and technetium‑99m phosphonate SPECT/CT; if the SPECT/CT findings are abnormal, a cardiac magnetic resonance scan (CMR) may be performed. The researchers will quantify imaging measures (for example, myocardial tracer uptake and extracellular volume) from those scans and record clinical information. Standardized follow-up checks are planned at about 6, 12, and 24 months; the study is observational and does not change your routine clinical care or diagnostic pathway.

How the study is structured. A prospective observational cohort that does not alter usual care. Participants receive clinically indicated imaging: echocardiography, photon-counting CT, and Tc99-SPECT/CT; if SPECT/CT is abnormal, CMR is performed per clinical practice. SPECT/CT data will be post-processed to quantify myocardial tracer uptake. Standardized clinical follow-up is planned at 6, 12, and 24 months to record cardiac outcomes.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Amyloidosis Cardiac; Stenosis Coronary; TAVI(Transcatheter Aortic Valve Implantation). Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Important dates

Study start
Jan 14, 2020
Primary completion
Dec 31, 2027 (estimated)
Study completion
Jun 30, 2028 (estimated)
Target enrollment
600 participants (estimated)
Last updated on registry
Sep 2, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Hospital Tuebingen
Collaborators
  • Bayer

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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