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OpenTrials
Completed

NCT Number: NCT03068364

Biological and Electrocardiographic Biomarkers for Risk Stratification in Hypertension.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Who can participate

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

  • 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.
  • Exclusion Criteria:
  • Patients refusal

Treatment and study plan

Primary outcomes

  1. All- cause and cardiovascular mortality in hypertension

    Time frame: 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 outcomes

  1. All-cause and cardiovascular deaths

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Additive Value of Biological and Electrocardiographic Biomarkers for Risk Stratification in Hypertension

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2017
Registry last updated
Mar 9, 2017

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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