NCT02221141

Brief Summary

The purpose of this study is to determine the prevalence in Belgium of Fabry disease in patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to determine in Fabry patients which was the most frequently initial symptom. Actually the early diagnosis is important because a treatment exists that can prevent future complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

7.3 years

First QC Date

August 18, 2014

Last Update Submit

August 19, 2024

Conditions

Left Ventricular Hypertrophy

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with left ventricular hypertrophy

You may qualify if:

  • unexplained left ventricular hypertrophy

You may not qualify if:

  • isolated septal hypertrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dinant-Godinne

Yvoir, 5530, Belgium

Location

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Laurence GABRIEL

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations

BE(1)