Fabry DiseaseFIESTA-MRINCT04856059
Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI
A study testing Cardiac MRI, ECG/Holter and Blood Biomarkers in people with Fabry Disease, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fabry Disease
- What is being tested?
- Cardiac MRI, ECG/Holter and Blood Biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2021to 31 Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fabry disease;
- Age ≥ 18 years.
Who cannot join
- History of myocardial infarction;
- Contraindication to MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Kate Hanneman, MD, 416-323-6400 ext. 5521, Kate.Hanneman@uhn.ca
About this study
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.
Read the detailed 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.
- Conditions
- Fabry Disease
- Being tested
- Cardiac MRI, ECG/Holter and Blood Biomarkers
- Keywords
- Fabry disease, Fabry cardiomyopathy, cardiac MRI, CMR, T1 mapping, T2mapping
- Medical subject headings
- Fabry Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI, ECG/Holter and Blood BiomarkersDiagnostic test
Cardiac MRI including T1/T2 mapping, ECG and blood biomarker evaluation will be performed at baseline and follow-up
| Study group | Role | What they receive |
|---|---|---|
| Cardiac MRI, ECG and Blood Biomarkers | Other | Additional sequences will be performed during routine clinical cardiac MRI and additional blood samples will be collected during routine blood work. Receives: Diagnostic Test: Cardiac MRI, ECG/Holter and Blood Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start15 Jun 2021
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fabry DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cardiac MRI
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Kate Hanneman, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856059
- Sponsor's protocol ID
- 21-5167
- Acronym
- FIESTA-MRI
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No