NCT02841696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

February 9, 2022

Status Verified

July 1, 2016

Enrollment Period

2.7 years

First QC Date

July 20, 2016

Last Update Submit

February 8, 2022

Conditions

Keywords

Heart failureSystolic dysfunctionGLSArterial stiffnessLeft ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Hypertensive people

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

Device: Cardiac echography

Interventions

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.

Hypertensive people

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Oral refusal of patient participation or its legal representatives, reading the specific information note for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

HypertensionHeart FailureHypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart DiseasesCardiomegalyHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Paul PEREZ, MD

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 22, 2016

Study Start

September 14, 2016

Primary Completion

May 15, 2019

Study Completion

May 15, 2019

Last Updated

February 9, 2022

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations