- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841696
Predictive Factors of Systolic Dysfunction in Non-complicated Hypertensive Patients (GLOBAL-HTN)
Predictive Factors of Systolic Dysfunction in Non-complicated Hypertensive Patients (GLS OBservationAL Study in HyperTensioN - GLOBAL-HTN)
Study Overview
Detailed Description
Some of the hypertensive patients will develop a post hypertensive heart disease. This hypertrophic cardiomyopathy is now essentially defined by the association of LV hypertrophy and diastolic dysfunction. Investigators believe this hypertrophic cardiomyopathy is also characterized by early impairment of systolic function but mainly in its longitudinal component (assessed by measuring the GLS) and therefore exposed to cardiovascular events.
The work is based on an existing cohort of hypertensive patients included more than 10 years ago before any initiation of antihypertensive therapy in the hypertension unit of the Bordeaux University Hospital, France. Patients will be contacted for further consultation with a cardiologist to identify patients with a LV systolic dysfunction. The primary end-point is a decrease of the longitudinal systolic function with a GLS<-17% for men and <-19% for women.
A sufficient number of patients will be contacted in order to collect data of at least 400 patients after more than 10-year of follow-up.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bordeaux, France, 33000
- University Hospital Bordeaux
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Subject with a confirmed hypertension before any anti-hypertensive treatment more than 10 years ago.
Patients are selected according their date of inclusion in the cohort. The investigators will start to contact the most recently recruited patients.
Description
Inclusion Criteria:
- Patient who was diagnosed as hypertensive more than 10 years ago and who underwent cardiac-echography, ECG, a biological blood test and an ambulatory blood pressure measurement before the introduction of antihypertensive treatment.
Exclusion Criteria:
- Oral refusal of patient participation or its legal representatives, reading the specific information note for the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Hypertensive people
Hypertensive people recruited 10 years ago before any anti-hypertensive treatment
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The exam is in the left lateral decubitus position.
4 electrodes are applied to the patient's chest for a synchronization with the Electrocardiogram (ECG).
The examination is conducted as standard with acquisition loops of records in parasternal long axis parasternal short axis, apical 4-cavities, 2-cavities and aorta 2 cavities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measure of GLS
Time Frame: Day 1
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GLS measurement is a percentage obtained on cuts apical 4-chamber, 2-aortic cavities and 2 cavities (average of 3 impacts) after locating the aortic pulsed Doppler of the opening and closing of the aortic valve. GLS < -17% for men and < -19% for women. |
Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Paul PEREZ, MD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2014/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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