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NCT Number: NCT04856059

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

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.

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Key information

Conditions

Fabry Disease Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Sphingolipidoses Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location status: Recruiting

Location contact

Kate Hanneman, MD

CONTACT

[email protected]

416-323-6400 ext. 5521

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fabry disease;
  • Age ≥ 18 years.

Exclusion criteria

  • History of myocardial infarction;
  • Contraindication to MRI.

Treatment and study plan

Cardiac MRI, ECG/Holter and Blood Biomarkers

Diagnostic Test

Cardiac MRI including T1/T2 mapping, ECG and blood biomarker evaluation will be performed at baseline and follow-up

Primary outcomes

  1. Major Adverse Cardiac Events (MACE)

    Time frame: 5 years

    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.

Secondary outcomes

  1. The FAbry STabilization indEX (FASTEX) score

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Hanneman

CONTACT

[email protected]

416-323-6400 ext. 5521

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Alberta Health services
  • IRCCS Policlinico S. Donato
  • Icahn School of Medicine at Mount Sinai
  • Libin Cardiovascular Institute of Alberta
  • The Cleveland Clinic
  • Vancouver Coastal Health
  • Vancouver General Hospital

Registry information

Acronym: FIESTA-MRI

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Apr 22, 2021
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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