NCT06956573

Brief Summary

We will conduct a retrospective study aiming to define the characteristics, determinants, and progression of ascending aortic dilatation in adults with Fabry disease, using echocardiography and/or cardiac MRI

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

May 2, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2026

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

April 16, 2025

Last Update Submit

May 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximum ascending aortic diameter measured by transthoracic echocardiography or cardiac MRI, expressed as a Z-score.

    At baseline

Interventions

Retrospective analysis of imaging data (echocardiography and/or cardiac MRI) in adult patients with Fabry disease to assess ascending aortic diameters.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with Fabry disease

You may not qualify if:

  • Patient refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fabry Disease

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 4, 2025

Study Start

May 2, 2025

Primary Completion

May 2, 2025

Study Completion

May 2, 2026

Last Updated

May 4, 2025

Record last verified: 2025-04