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

NCT06799273 | Recruiting

• 1 other identifier: MECKI-AMYLOIDOSIS
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the parameters most closely correlated with two-year prognosis in patients with cardiac amyloidosis in order to create a specific risk score for these patients.

  2 years

Study Arms (2)

Amyloidosis patients (prospective cohort)

Prospectively enrolled patients diagnosed with cardiac amyloidosis

Heart Failure patients (retrospective cohort)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective Cohort: Patients with Diagnosis of cardiac amyloidosis. Retrospective cohort: Population of heart failure patients selected from the MECKI score database

You may qualify if:

• Age \> 18 years
• Diagnosis of cardiac amyloidosis obtained by MRI or scintigraphy
• Ability to perform a cardiopulmonary exercise test

You may not qualify if:

• severe obstructive pulmonary disease
• exercise-induced angina
• significant ECG changes
• presence of clinical comorbidities that interfere with exercise performance

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead

Study Sites (1)

Centro Cardiologico Monzino, Irccs

Milan, Italy, 20138, Italy

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

piergiuseppe Agostoni, MD, PhD

CONTACT

0258002772; piergiuseppe.agostoni@cardiologicomonzino.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: May 7, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)