Screening, Characterization, and Longitudinal Follow-up of Patients With Cardiac Amyloidosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
Cardiac amyloidosis is a progressive disorder caused by extracellular deposition of amyloid fibrils in the heart, leading to heart failure and impaired cardiac function. Early diagnosis and targeted therapies are essential to improve patient outcomes. This prospective, single-center study aims to longitudinally follow patients with suspected cardiac amyloidosis to characterize disease progression and assess treatment effects. Participants will undergo cardiac magnetic resonance imaging (resting and exercise stress MRI), magnetic resonance spectroscopy, cardiopulmonary exercise testing (spiroergometry) and blood testing at baseline and at 6, 12, and 24 months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Male and female patients undergoing clinically indicated diagnostic work-up for amyloidosis or with a previously confirmed diagnosis of cardiac amyloidosis prior to initiation of therapy
Presence of left ventricular wall thickness > 12 mm on transthoracic echocardiography and at least one "red flag" suggestive of cardiac amyloidosis (according to ESC 2021 criteria) or an otherwise clinically established suspicion of amyloidosis
Written informed consent
Disqualifiers
Age < 18 years
Contraindications to cardiac MRI (e.g., metallic foreign bodies, older-generation pacemakers, severe obesity, claustrophobia)
Lack of written informed consent for study participation
Inability to comply with the study procedures
Trial population
Patients with Cardiac Amyloidosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Changes in myocardial structural parameters
measured by Cardiac Magnetic Resonance Tomography
Time frame
after 6 and 12 months2
Changes in myocardial function
measured by cardiac magnetic resonance
Time frame
after 6 and 12 months3
Changes in myocardial metabolism under therapy
measured by MR spectroscopy
Time frame
after 6 and 12 monthsSecondary outcomes
1
Changes in heart rate reserve
measured by functional exercise testing
Time frame
after 6 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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