Predictive Factors of Systolic Dysfunction in Non-complicated Hypertensive Patients

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.

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Key information

Conditions

Hypertension Cardiomegaly Cardiovascular Diseases Heart Diseases Heart Failure Hypertrophy Hypertrophy, Left Ventricular Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac echography

Device

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.

Primary outcomes

Measure of GLS

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: GLOBAL-HTN

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jul 22, 2016
Registry last updated: Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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