Biological and Electrocardiographic Biomarkers for Risk Stratification in Hypertension.

Completed

• Conditions: Hypertension

• Registration Number: NCT03068364
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Risk stratification of hypertensive patients includes assessment of traditional cardiovascular risk factors and subclinical target organ damages particularly left ventricular hypertrophy (LVH).

LVH may routinely screened by transthoracic echocardiography by measuring the left ventricular mass (LVM).

However, transthoracic echocardiography suffers from several pitfalls: poor reproducibility, technical limitations and unavailability at a first evaluation by general practitioners.

Other biomarkers may be particularly helpful in hypertension risk stratification. The amplitude of the R wave in aVL lead is a simple validated ECG parameters of LVH and a strong predictor of cardiovascular events and mortality.

Plasma N-terminal pro Brain Natriuretic Peptide (NT-proBNP) is also strongly related to LVM and is an independent predictor of all-cause mortality in hypertension.

The main objective of our study is to determine the additive prognostic value of R wave in aVL and NT proBNP on all-cause and cardiovascular mortality.

Secondary objectives are to determine the addition prognostic value of NT-proBNP and R wave in aVL combined in comparison to each marker taken into account

This study will include 1600 patients who had a work-up of their hypertension in the Cardiology Department of Croix-Rousse Hospital (Hospices Civils de Lyon, Lyon, France) from January 1997 to January 2014.

Their data will be collected in an Access database; their vital status will be obtained by the INSEE unit CépiDC.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-03
• Primary Completion: 2017-02-17
• Study Completion: 2017-02-17
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-02-27
• Status Verified: 2017-03
• Study First Posted: 2017-03-01
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• >18 years old
  • men or women
  • questionnaire completion and physical exam during their first stay in the Cardiology Department of from January 1997 to January 2014.

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Exclusion Criteria

• Patients refusal

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All- cause and cardiovascular mortality in hypertension	an average of 7 years	All-Cause and cardiovascular mortality will be obtained from the INSERM unit CépiDC.; Vital status was obtained in July 2016

Secondary Outcome Measures

Name	Time	Method
All-cause and cardiovascular deaths	an average of 7 years	All-cause and cardiovascular deaths in the study population will be obtained from the INSERM unit CépiDC.; Vital status was obtained in July 2016

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse; 🇫🇷 Lyon, France