NCT06884358 Functional Capacity in Anderson-Fabry Disease Patients
| NCT ID | NCT06884358 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Policlinico S. Donato |
| Condition | Anderson-Fabry Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2031-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-11-13 with a primary completion date of 2031-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients with a genetic diagnosis of AFD, according to current guidelines; * Informed written consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care (for patients age \<18 years old, written consent from a caregiver is mandatory). Exclusion Criteria: * eGFR \<30 ml/min and other contraindications for CMR (relative controindication: patients with implantable device); * Musculoskeletal limitation for exercise test on the cyclo ergometer; * Pregnant or breastfeeding women; * Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a full comprehension of the written consent form.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06884358 clinical trial?
This trial is open to participants of all sexes, studying Anderson-Fabry Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06884358 currently recruiting?
Yes, NCT06884358 is actively recruiting participants. Contact the research team at massimo.piepoli@grupposandonato.it for enrollment information.
Where is the NCT06884358 trial being conducted?
This trial is being conducted at Brescia, Italy, Milan, Italy, San Donato Milanese, Italy, Monza, Italy and 1 additional location.
Who is sponsoring the NCT06884358 clinical trial?
NCT06884358 is sponsored by IRCCS Policlinico S. Donato. The trial plans to enroll 100 participants.