Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI

Fabry Disease Clinical Trial

— FIESTA-MRI  

Official title:

Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856059
• Other study ID #: 21-5167
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: Kate Hanneman
• Phone: 416-323-6400
• Email: kate.hanneman[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate whether cardiac MRI T1 and T2 mapping improves our ability to detect early abnormalities in the heart in patients with Fabry disease and identify patients at increase risk of adverse events.

Description:

Fabry disease is an inherited disorder that affects many organs in the body, including the heart. Men and women are both affected, with average life expectancy reduced by 10-20 years. The heart muscle can become thick and scarred in over half of patients, eventually resulting in heart failure, abnormal rhythm and death. The focus of this study will be on improving the detection of early heart disease before irreversible damage has occurred in order to improve patient outcomes.

It is hypothesized that new cardiac MRI techniques called T1 and T2 mapping will improve the ability to detect early abnormalities in the heart. Early detection of cardiac disease may enable a personalized treatment approach, potentially improving patient outcomes. The results of the study will identify which patients might benefit from early initiation of treatment to prevent bad outcomes in the future by using cardiac MRI to identify those at higher risk.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Fabry disease;

• Age = 18 years.

Exclusion Criteria:

• History of myocardial infarction;

• Contraindication to MRI.

Related Conditions & MeSH terms

• Cardiomyopathies
• Fabry Disease

Intervention

Diagnostic Test:
• Cardiac MRI, ECG/Holter and Blood Biomarkers
Cardiac MRI including T1/T2 mapping, ECG and blood biomarker evaluation will be performed at baseline and follow-up

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (9)

Lead Sponsor	Collaborator
University Health Network, Toronto	Alberta Health services, Icahn School of Medicine at Mount Sinai, IRCCS Policlinico S. Donato, Libin Cardiovascular Institute of Alberta, Mayo Clinic, The Cleveland Clinic, University of Colorado, Denver, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)	MACE will be assessed as a composite endpoint defined by the development on one or more of events such as sustained ventricular tachycardia (VT), severe bradycardia, heart failure hospitalization and cardiac death.	5 years
Secondary	The FAbry STabilization indEX (FASTEX) score	FAbry STabilization indEX (FASTEX) score will be evaluated to assess clinical stability or progression of Fabry disease at follow-up.; FASTEX score change of =20% will be considered an indication of clinical worsening at follow-up.; Minimum value 0%. No maximum value. Higher score change indicates worse outcome.	3 years