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RecruitingNCT06169358SEARCHUpdated Dec 13, 2023

Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy

An observational study in Hypertrophic Cardiomyopathy, Left Ventricular Hypertrophy and Fabry Disease, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Qilu Hospital of Shandong University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
627
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study was to understand the epidemiological status of Fabry in patients with hypertrophic cardiomyopathy or left ventricular hypertrophy through multi-center early identification of high-risk patients in cardiology according to high-risk profiles, supplemented by DBS (dried blood disc) screening tools, and to explore the screening and diagnosis methods of patients with Fabry disease in cardiology, so as to promote the early identification, diagnosis and treatment of Fabry in cardiology.

02

Conditions studied

  • Hypertrophic Cardiomyopathy
  • Left Ventricular Hypertrophy
  • Fabry Disease
03

In context

Cardiomyopathy, Hypertrophic

363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.

This study's planned enrollment of 627 is above the median of 259 across 174 observational studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Clinical case collection of patients with hypertrophic cardiomyopathy or left ventricular hypertrophy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meet diagnostic criteria for hypertrophic cardiomyopathy (HCM) in adults (age ≥ 18 years):Imaging of one or more left ventricular segments reveals a maximum end-diastolic ventricular wall thickness of ≥15 mm or end-diastolic ventricular septal thickness or posterior left ventricular wall thickness of ≥13 mm on either cardiac imaging at rest.

Exclusion criteria

Exclusion Criteria:

    1. Identification of hypertrophic cardiomyopathy caused by mutations in pathogenic genes; 2. Identify the cause of left ventricular hypertrophy (LVH); 3. Aortic valve or mitral valve lesions that can cause hemodynamic changes.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
627 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. diagnosis of Fabry disease

    Clinicians can identify high-risk patients in cardiology at an early stage according to the high-risk profile developed in this study, supplemented by the DBS (dried blood disc) screening tool, and diagnose and treat Fabry disease as early as possible through the established screening pathway for high-risk patients with Fabry disease in cardiology.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Sep 2024, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2023
First posted
Dec 13, 2023
StartActual
Oct 1, 2023
Primary completionEst.
Sep 1, 2024
CompletionEst.
Sep 1, 2024
Last update
Dec 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06169358
Responsible party
Sponsor
First posted
Dec 13, 2023
Start date
Oct 1, 2023
Primary completion
Sep 1, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Dec 13, 2023

Study contacts

Xinyu Zhang
Contact
zhangxinyu@sdu.edu.cn
18560087699
Xiaoping Ji
study chair · Qilu Hospital of Shandong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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