MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis (MECKI-AMI)

Centro Cardiologico Monzino

Status: Enrolling

Conditions: Cardiac Amyloidosis

Study type: Observational

Funder types: Other

Identifiers

NCT06799273

MECKI-AMYLOIDOSIS

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,400 participants in 2 patient groups

Amyloidosis patients (prospective cohort)

Description:

Prospectively enrolled patients diagnosed with cardiac amyloidosis

Heart Failure patients (retrospective cohort)

Description:

Patients with history of heart failure with reduced ejection fraction previously enrolled in the MECKI score registry