GLOBAL-HTN: Predictive Factors of Systolic Dysfunction in Non-complicated Hypertensive Patients

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT02841696
Collaborator
(none)
183
1
32
5.7

Study Details

Study Description

Brief Summary

Hypertension is a major cardiovascular risk factor. Heart failure is one of its main complications but the factors that influence its development are still insufficiently known. The primary objective is to determine associated factors to the occurrence of left ventricular (LV) systolic dysfunction assessed by an alteration of the Global Longitudinal Strain (GLS) after more than the years of hypertension. The secondary objective is to estimate the prevalence of LV systolic dysfunction in a cohort of hypertensive people followed for over 10 years and formulate pathophysiological hypotheses on the development of this heart disease.

Condition or Disease Intervention/Treatment Phase
  • Device: Cardiac echography

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 Design

Study Type:
Observational
Actual Enrollment :
183 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Predictive Factors of Systolic Dysfunction in Non-complicated Hypertensive Patients (GLS OBservationAL Study in HyperTensioN - GLOBAL-HTN)
Actual Study Start Date :
Sep 14, 2016
Actual Primary Completion Date :
May 15, 2019
Actual Study Completion Date :
May 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Hypertensive people

Hypertensive people recruited 10 years ago before any anti-hypertensive treatment

Device: Cardiac echography
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.

Outcome Measures

Primary Outcome Measures

  1. Measure of GLS [Day 1]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Bordeaux Bordeaux France 33000

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

  • Study Chair: Paul PEREZ, MD, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT02841696
Other Study ID Numbers:
  • CHUBX 2014/07
First Posted:
Jul 22, 2016
Last Update Posted:
Feb 9, 2022
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2022