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Recruiting NCT06758648

NCT06758648 Characterizing the Retinal Microvasculature in Patients with Fabry Disease: a Prospective Observational Study

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Clinical Trial Summary
NCT ID NCT06758648
Status Recruiting
Phase
Sponsor Technical University of Munich
Condition Fabry Disease
Study Type OBSERVATIONAL
Enrollment 63 participants
Start Date 2020-06-25
Primary Completion 2021-09-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Dynamic retinal vessel analysis (DVA)Biochemistry and immune phenotypingQuestionnaires (Patient reported outcomes)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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 63 participants in total. It began in 2020-06-25 with a primary completion date of 2021-09-01.

⚠ 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

This study aims to gain a deeper understanding of endothelial dysfunction in patients with Fabry disease through a prospective study of the retinal microvasculature and to identify an objective, non-invasive marker to assess disease severity and cardiovascular risk in patients. The main questions addressed are: Do dynamic and static retinal vessel analysis parameters differ from those in healthy individuals? Can these parameters predict cardiovascular and/or Fabry-related events during follow-up? Do these parameters change during follow-up in patients with a non-stable disease?

Eligibility Criteria

Inclusion Criteria: * Age \> 18 years * Diagnosis of Fabry disease by genetic testing or GB3 activity in leukocytes. * Signed informed consent form Exclusion Criteria: * Active infection or cancer * Surgery less than 2 weeks prior to inclusion in the study * Known glaucoma * Lack of capacity to give consent; lack of informed consent. * Known epilepsy

Contact & Investigator

Central Contact

Christoph Schmaderer, Prof. Dr.

✉ christoph.schmaderer@mri.tum.de

📞 089 4140 5053

Principal Investigator

Roman Günthner, PD Dr.

PRINCIPAL INVESTIGATOR

Abteilung für Nephrologie

Frequently Asked Questions

Who can join the NCT06758648 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying 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 NCT06758648 currently recruiting?

Yes, NCT06758648 is actively recruiting participants. Contact the research team at christoph.schmaderer@mri.tum.de for enrollment information.

Where is the NCT06758648 trial being conducted?

This trial is being conducted at München, Germany.

Who is sponsoring the NCT06758648 clinical trial?

NCT06758648 is sponsored by Technical University of Munich. The principal investigator is Roman Günthner, PD Dr. at Abteilung für Nephrologie. The trial plans to enroll 63 participants.

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