Left Ventricular HypertrophyNCT02221141
Screening of Fabry Disease in Patients With Left Ventricular Hypertrophy Detected in Echocardiography
An observational study of Left Ventricular Hypertrophy, run by Laurence Gabriel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Hypertrophy
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with left ventricular hypertrophy
Who may be able to join
- unexplained left ventricular hypertrophy
Who cannot join
- isolated septal hypertrophy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Left Ventricular Hypertrophy
- Medical subject headings
- Hypertrophy, Left Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2021
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laurence Gabriel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laurence Gabriel, Centre Hospitalier Universitaire UCLouvain Namur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221141
- Sponsor's protocol ID
- Fabry Disease Cardioscreening
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2014
- Last updated
- 20 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Fabry Disease in Patients With Left Ventricular Hypertrophy Detected in Echocardiography
- ClinicalTrials.gov ID
- NCT02221141
- Acronym / sponsor ID
- Fabry Disease Cardioscreening
- Conditions
- Left Ventricular Hypertrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Laurence GabrielUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with left ventricular hypertrophy
Key inclusion criteria (1 listed)
- unexplained left ventricular hypertrophy
Key exclusion criteria (1 listed)
- isolated septal hypertrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Hypertrophy, run by Laurence Gabriel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with left ventricular hypertrophy who have Fabry Disease mutation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.