Biological and Electrocardiographic Biomarkers for Risk Stratification in Hypertension.

NCT03068364 | Completed

• 1 other identifier: 69HCL17_0151
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Mortality; Hypertension; Left ventricular hypertrophy; NT-proBNP; ECG; Transthoracic echocardiography

Outcome Measures

Primary Outcomes (1)

• All- cause and cardiovascular mortality in hypertension

  All-Cause and cardiovascular mortality will be obtained from the INSERM unit CépiDC. Vital status was obtained in July 2016

  an average of 7 years

Secondary Outcomes (1)

• All-cause and cardiovascular deaths

  an average of 7 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \>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.

You may not qualify if:

• Patients refusal

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Hypertension; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cardiomegaly; Heart Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre LANTELME

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 1, 2017
• Study Start: November 3, 2016
• Primary Completion: February 17, 2017
• Study Completion: February 17, 2017
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

FR (1)