250 Participants Needed

Multiparametric MRI for Fabry Cardiomyopathy

(FIESTA-MRI Trial)

KH
Overseen ByKate Hanneman
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Cardiac MRI for Fabry Cardiomyopathy?

Cardiac MRI is effective in diagnosing and monitoring Fabry cardiomyopathy by measuring heart function, volume, and mass, and detecting early signs of heart involvement, which helps in managing the disease and improving patient outcomes.12345

Is cardiac MRI safe for humans?

Cardiac MRI is generally safe, but some people may experience mild reactions to the contrast agent used, like gadolinium, which can cause temporary side effects. It's important to note that people with certain heart devices, like pacemakers, need special precautions during the procedure.678910

How is cardiac MRI used as a treatment for Fabry cardiomyopathy different from other treatments?

Cardiac MRI is unique for Fabry cardiomyopathy because it is a noninvasive imaging technique that helps diagnose and monitor the disease by assessing heart structure and function, and detecting early signs of heart involvement, unlike other treatments that may focus on managing symptoms or enzyme replacement.2341112

What is the purpose of this trial?

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.

Research Team

KH

Kate Hanneman, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults over 18 with Fabry disease, aiming to detect early heart issues. It's not suitable for those who've had a heart attack or can't undergo MRI scans due to health risks or implanted medical devices.

Inclusion Criteria

I have Fabry disease.

Exclusion Criteria

I have had a heart attack before.
You cannot have an MRI for medical reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cardiac MRI and Biomarker Assessment

Participants undergo cardiac MRI, ECG, and blood biomarker assessments to detect early myocardial abnormalities

1-2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for major adverse cardiac events and changes in the FASTEX score

5 years
Periodic visits (in-person)

Treatment Details

Interventions

  • Cardiac MRI
Trial Overview The study tests if advanced cardiac MRI techniques can spot early signs of heart damage in Fabry patients and predict future complications better than traditional methods.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Cardiac MRI, ECG and Blood BiomarkersExperimental Treatment1 Intervention
Additional sequences will be performed during routine clinical cardiac MRI and additional blood samples will be collected during routine blood work.

Cardiac MRI is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Cardiac MRI for:
  • Congenital heart disease
  • Cardiomyopathies
  • Valvular heart disease
  • Diseases of the aorta
  • Coronary heart disease
  • Cardiac tumors
πŸ‡ΊπŸ‡Έ
Approved in United States as Cardiac MRI for:
  • Coronary heart disease
  • Congenital heart defects
  • Heart valve problems
  • Pericarditis
  • Cardiac tumors
  • Myocardial infarction
πŸ‡¨πŸ‡¦
Approved in Canada as Cardiac MRI for:
  • Cardiomyopathies
  • Valvular heart disease
  • Diseases of the aorta
  • Coronary heart disease
  • Cardiac tumors
  • Myocardial infarction
πŸ‡―πŸ‡΅
Approved in Japan as Cardiac MRI for:
  • Congenital heart disease
  • Cardiomyopathies
  • Valvular heart disease
  • Diseases of the aorta
  • Coronary heart disease
πŸ‡¨πŸ‡³
Approved in China as Cardiac MRI for:
  • Congenital heart disease
  • Cardiomyopathies
  • Valvular heart disease
  • Diseases of the aorta
  • Coronary heart disease
πŸ‡¨πŸ‡­
Approved in Switzerland as Cardiac MRI for:
  • Congenital heart disease
  • Cardiomyopathies
  • Valvular heart disease
  • Diseases of the aorta
  • Coronary heart disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

IRCCS Policlinico S. Donato

Collaborator

Trials
102
Recruited
108,000+

Alberta Health services

Collaborator

Trials
168
Recruited
658,000+

Libin Cardiovascular Institute of Alberta

Collaborator

Trials
4
Recruited
650+

Vancouver General Hospital

Collaborator

Trials
42
Recruited
19,700+

The Cleveland Clinic

Collaborator

Trials
1,072
Recruited
1,377,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials
933
Recruited
579,000+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

Findings from Research

Cardiac magnetic resonance feature tracking (CMR-FT) effectively identifies myocardial dysfunction in Fabry disease (FD) patients, showing significant reductions in global longitudinal strain (GLS) across all stages of the disease compared to healthy controls.
The study, involving 20 FD patients and 20 healthy controls, indicates that CMR-FT can track disease severity, with the most severe myocardial impairment observed in patients with advanced disease stages, suggesting its potential as a valuable tool for monitoring FD progression.
Quantification of myocardial deformation in patients with Fabry disease by cardiovascular magnetic resonance feature tracking imaging.Zhao, L., Zhang, C., Tian, J., et al.[2022]
Cardiac MRI is essential for diagnosing cardiac involvement in Fabry disease, as it helps assess heart function, volume, and mass, which are critical for evaluating patient prognosis.
Measuring native myocardial T1 values through cardiac MRI can lead to early detection of cardiac issues, while tracking left ventricular myocardial mass can help monitor treatment effectiveness in patients with Fabry disease.
[The Role of Cardiac MRI in the Diagnosis of Fabry Disease].Hong, YJ., Kim, YJ.[2022]
Fabry disease is a rare genetic disorder caused by a deficiency of the Ξ±-galactosidase A enzyme, leading to harmful accumulation of certain substances in various organs, particularly affecting the heart and kidneys.
Early diagnosis and treatment of Fabry disease are crucial to prevent serious complications like heart failure, and cardiovascular magnetic resonance imaging plays a key role in diagnosing and monitoring the effectiveness of treatments.
Cardiac MRI in Fabry disease.Umer, M., Kalra, DK.[2023]

References

Quantification of myocardial deformation in patients with Fabry disease by cardiovascular magnetic resonance feature tracking imaging. [2022]
[The Role of Cardiac MRI in the Diagnosis of Fabry Disease]. [2022]
Cardiac MRI in Fabry disease. [2023]
Fabry Disease: More than a Phenocopy of Hypertrophic Cardiomyopathy. [2023]
Clinical and CMR characteristics associated with cardiac events in patients with Fabry disease. [2023]
Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]
Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry. [2022]
Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. [2016]
Cardiovascular magnetic resonance at 0.5T in five patients with permanent pacemakers. [2006]
Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. [2021]
Advanced CMR Techniques in Anderson-Fabry Disease: State of the Art. [2023]
Quantitative comparison of 2D and 3D late gadolinium enhancement MR imaging in patients with Fabry disease and hypertrophic cardiomyopathy. [2022]
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