ClinicalTrials.gov record NCT04856059

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationCanada
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This diagnostic study tests whether cardiac MRI techniques (T1 and T2 mapping) can detect early structural and tissue changes in the hearts of adults with Fabry disease. Participants will have cardiac MRI scans including T1/T2 mapping, ECG/Holter monitoring, and blood biomarker tests at baseline and during follow-up. The study will track major adverse cardiac events over time and assess clinical stability or progression using the FASTEX score.

What it is studying. Whether cardiac MRI T1 and T2 mapping identifies early myocardial structural and tissue abnormalities and whether those imaging findings are associated with higher risk of major adverse cardiac events in Fabry disease.

What the researchers hope to learn. To find out if T1 and T2 cardiac MRI can improve detection of early heart involvement in Fabry disease and to identify MRI and biomarker features linked to higher risk of major adverse cardiac events (MACE) or clinical worsening as measured by the FASTEX score.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • Cardiac MRI, ECG/Holter and Blood Biomarkers

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Fabry disease;
  • Age ≥ 18 years.

Exclusion criteria

  • History of myocardial infarction;
  • Contraindication to MRI.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have a cardiac MRI that includes T1 and T2 mapping, plus heart rhythm testing (ECG and Holter) and blood biomarker tests at baseline and at follow-up visits. Additional MRI sequences may be added during routine clinical cardiac MRI and extra blood samples may be taken during routine blood work. The study will track clinical outcomes over time, with assessments performed during follow-up (primary outcomes are assessed over a 5-year timeframe).

How the study is structured. An interventional diagnostic study with a single group and no masking. Adults with Fabry disease receive cardiac MRI (including T1/T2 mapping), ECG/Holter monitoring, and blood biomarker collection at baseline and at follow-up visits. Key outcome timeframes reported are 5 years for major adverse cardiac events and 3 years for change in the FASTEX clinical stability score.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Canada. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Fabry disease

Clinical trials47 trials listed for Fabry diseaseEvery trial the registry lists for Fabry disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Fabry disease researchLatest monthly update: September 2026. Includes: SGLT2 outcome link. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 15, 2021
Primary completion
Mar 31, 2029 (estimated)
Study completion
Mar 31, 2029 (estimated)
Target enrollment
300 participants (estimated)
Last updated on registry
Apr 16, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Health Network, Toronto
Collaborators
  • Vancouver General Hospital
  • The Cleveland Clinic
  • Icahn School of Medicine at Mount Sinai
  • IRCCS Policlinico S. Donato
  • Alberta Health services
  • Libin Cardiovascular Institute of Alberta
  • Vancouver Coastal Health

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
Contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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