NCT06799273 MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis
| NCT ID | NCT06799273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro Cardiologico Monzino |
| Condition | Cardiac Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2026-05 |
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 1,400 participants in total. It began in 2024-05-07 with a primary completion date of 2026-05.
⚠ 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
This study aims to advance the understanding of cardiac amyloidosis, its effects on exercise capacity, and its prognostic implications. By conducting a systematic investigation with particular emphasis on longitudinal evaluation, we aim to provide valuable insights to guide clinical practice and improve the management of patients with cardiac amyloidosis. 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.
Eligibility Criteria
Inclusion criteria * Age \> 18 years * Diagnosis of cardiac amyloidosis obtained by MRI or scintigraphy * Ability to perform a cardiopulmonary exercise test Exclusion criteria * severe obstructive pulmonary disease * exercise-induced angina * significant ECG changes * presence of clinical comorbidities that interfere with exercise performance
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06799273 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Cardiac Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06799273 currently recruiting?
Yes, NCT06799273 is actively recruiting participants. Contact the research team at piergiuseppe.agostoni@cardiologicomonzino.it for enrollment information.
Where is the NCT06799273 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06799273 clinical trial?
NCT06799273 is sponsored by Centro Cardiologico Monzino. The trial plans to enroll 1,400 participants.