Impact of Enzyme Replacement Therapy on Cardiac Function in Patients With Fabry's Cardiomyopathy (RECAFTURE Trial)
NCT ID: NCT02469181
Last Updated: 2021-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2015-05-21
2024-10-31
Brief Summary
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Detailed Description
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2. Primary / Secondary Endpoint 1) Primary endpoint
* Changes of peak exercise E/E' by diastolic stress echocardiography (RECAP-F STRESS trial) and LV vortex flow parameters (RECAP-F FLOW trial) at 1 year follow up.
2\) Secondary endpoint
* Changes of extracellular volume by CMR(T1 mapping) at 1 year follow up (RECAP-F trial) ② Evaluation of the degree of the resting LV diastolic function ③ Other echo-parameters; LV mass index at baseline, 1 year follow up, reduction of peak exercise E/E prime at 1 year follow up
* Changes of quality of life using questionnaire ⑤ Change of peak VO2, exercise time, AT by diastolic stress echocardiography at 1 year follow up ⑥ Change in T1 baseline(myo, ms) \& T1 baseline(blood, ms) T1 postcontrast(myo, ms) \& T1 baseline(blood, ms) by CMR
3. Study Methods 1) Study Design : 28 patients with newly diagnosed genetically confirmed Anderson-Fabry's disease will undergo diastolic stress echocardiography, LV vortex flow analysis, and cardiac MRI before enzyme replacement therapy(ERT) (baseline study) and after 1 year of treatment with agalsidese beta at the dose of 1mg/kg (follow-up study).
2\) Study procedures : Examinations as described below will be done before ERT and 1 year later
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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FD(Fabry disease) group
28 patients with newly diagnosed genetically confirmed Anderson-Fabry's disease will undergo diastolic stress echocardiography, LV vortex flow analysis, and cardiac MRI before enzyme replacement therapy(ERT) (baseline study) and after 1 year of treatment with agalsidese beta at the dose of 1mg/kg (follow-up study).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* All patients should have LV hypertrophy in 2D echocardiography (end diastolic septum and posterior wall thickness ≥12mm)
* Patients provided with the written, informed consent to participate in this study
Exclusion Criteria
* Patients who cannot perform supine bicycle stress echocardiography, contrast echocardiography or cardiac MRI
* Hemodynamically significant valvular heart disease or arrythmias
* History of acute myocardial infarction or congestive heart failure with reduced LV ejection fraction of less than 35%
* CVA in the prior 6 months
* Scheduled or planned surgery in the next 6 months
* Chronic liver cirrhosis
* Allergy to contrast agent (Definity®, Lantheus Medical Imaging, North Billerica, MA, USA)
16 Years
75 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2014-0679
Identifier Type: -
Identifier Source: org_study_id
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