MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis
NCT ID: NCT06799273
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1400 participants
OBSERVATIONAL
2024-05-07
2027-05-31
Brief Summary
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Our study intends to follow patients for a period of two years, evaluating them every six months. This longitudinal approach allows us to monitor changes in exercise capacity and other relevant clinical parameters over time. Furthermore, it enables the development of a prognostic tool similar to the MECKI score, capable of assessing the risk of adverse events in patients with cardiac amyloidosis based on their exercise performance.
By comparing our results with data from heart failure patients already included in the MECKI score database, we also aim to highlight any differences in prognosis between patients with cardiac amyloidosis and those with general heart failure. Finally, we aim to characterize cardiac amyloidosis by differentiating it from general heart failure. By comparing our results with data from heart failure patients already included in the MECKI score database, we can clarify the distinct exercise limitations in cardiac amyloidosis and shed light on how they differ from more conventional heart failure.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Amyloidosis patients (prospective cohort)
Prospectively enrolled patients diagnosed with cardiac amyloidosis
No interventions assigned to this group
Heart Failure patients (retrospective cohort)
Patients with history of heart failure with reduced ejection fraction previously enrolled in the MECKI score registry
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cardiac amyloidosis obtained by MRI or scintigraphy
* Ability to perform a cardiopulmonary exercise test
Exclusion Criteria
* exercise-induced angina
* significant ECG changes
* presence of clinical comorbidities that interfere with exercise performance
18 Years
100 Years
ALL
No
Sponsors
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Centro Cardiologico Monzino
OTHER
Responsible Party
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Locations
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Centro Cardiologico Monzino, Irccs
Milan, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MECKI-AMYLOIDOSIS
Identifier Type: -
Identifier Source: org_study_id
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