Assessing exercise capacity and prognosis in patients with cardiac amyloidosis
MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis
This study is testing how well people with cardiac amyloidosis can exercise and what that means for their health over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06799273 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding cardiac amyloidosis by evaluating the exercise capacity and prognostic implications for affected patients. Over a two-year period, participants will be assessed every six months to monitor changes in their exercise performance and other clinical parameters. The study aims to develop a prognostic tool similar to the MECKI score to evaluate the risk of adverse events based on exercise capacity. Additionally, it will compare findings with existing data from heart failure patients to identify differences in prognosis.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years diagnosed with cardiac amyloidosis through MRI or scintigraphy who can perform a cardiopulmonary exercise test.
Not a fit: Patients with severe obstructive pulmonary disease, exercise-induced angina, significant ECG changes, or other clinical comorbidities that hinder exercise performance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management and treatment strategies for patients with cardiac amyloidosis.
How similar studies have performed: While this approach is systematic and longitudinal, similar studies have shown promise in understanding heart failure, suggesting potential for success.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Milan, Italy
- Centro Cardiologico Monzino, Irccs — Milan, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: piergiuseppe Agostoni, MD, PhD
- Email: piergiuseppe.agostoni@cardiologicomonzino.it
- Phone: 0258002772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.