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NCT06884358 · ClinicalTrials.gov record · last posted 2026-07-02

Functional Capacity in Anderson-Fabry Disease Patients

Study acronym: OPTIMA-FD
StatusRecruiting
PhaseNot specified
Started2024-11-13
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The goal of this observational study is to observe the relation between excercise parameters - assessed by CPET - and rest/stress hemodynamic parameters - assessed by echocardiogram and CMR - in patients with a genetic diagnosis of Anderson-Fabry Disease. Participants will undergo: * baseline evaluation: clinical evaluation, disease staging with FASTEX and MSSI, KCCQ for quality of life assessment, resting 12-leads ECG, 6MWT, CPET-ESE and contrast-enhanced CMR; * before 36 months from baseline: resting 12-leads ECG, 2D rest and stress echocardiogram, CPET-ESE, contrast-enhanced CMR, disease staging with FASTEX and MSSI and KCCQ for quality of life assessment; * up to 7 years from baseline: clinical follow-up.

Amendment record 1 amendment on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended once since 2025-03-17. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT06884358
Lead Sponsor IRCCS Policlinico S. Donato
Conditions Anderson-Fabry Disease
Enrollment 100 participants
Start Date 2024-11-13
Primary Completion 2031-11 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-02