Predictive Factors of Systolic Dysfunction in Non-complicated Hypertensive Patients

Hypertension Clinical Trial

— GLOBAL-HTN  

Official title:

Predictive Factors of Systolic Dysfunction in Non-complicated Hypertensive Patients (GLS OBservationAL Study in HyperTensioN - GLOBAL-HTN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841696
• Other study ID #: CHUBX 2014/07
• Status: Completed
• Start date: September 14, 2016
• Est. completion date: May 15, 2019

Study information

• Verified date: July 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Systolic Murmurs

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of GLS	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