Echocardiographic Analysis by Artificial Intelligence in Hypertension

NCT06680986 | Recruiting

• 2 other identifiers: 69HCL22_0643898
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to develop artificial intelligence (AI) tools to characterize cardiac remodelling in arterial hypertension through the analysis of routine imaging data (echocardiography) coupled with patient data. More precisely, this study will make it possible (i) to represent in a relevant way the spectrum of the cardiac repercussions of a population affected by hypertension to better characterize the progress of the pathology, in particular vis-à-vis the more ambiguous subjects to be characterized ("grey" area); (ii) to develop tools for the automatic quantification of cardiac function (segmentation and robust monitoring of the myocardium during the cardiac cycle, for the dynamic analysis of the shape and global deformation of the heart) and therefore to extract descriptors richer in cardiac function than those currently used in clinical routine.

Conditions

Arterial Hypertension

Keywords

Hypertension; HTN; Arterial Hypertension; Artificial Intelligence; AI; Cardiac remodelling; Left ventricular hypertrophy

Outcome Measures

Primary Outcomes (3)

• Arterial Blood Pressure

  This measure will assess the arterial blood pressure in millimeters of mercury (mmHg). Blood pressure measurements will include both systolic and diastolic values. This measurement will be used to evaluate the severity of hypertension and track changes over the course of the study.

  Baseline

• Number of Antihypertensive Medications

  This measure will record the number of antihypertensive medications prescribed to each patient. The data will be used to assess the intensity of the treatment regimen required to control blood pressure levels in participants. Unit of Measure: Count of medications (integer)

  Baseline

• NT-proBNP Concentration

  This measure will assess plasma concentrations of N-terminal pro b-type natriuretic peptide (NT-proBNP), a biomarker correlated with left ventricular pressure and mass. NT-proBNP levels will be analyzed in picograms per milliliter (pg/mL) to evaluate cardiac stress associated with hypertension.

  Baseline

Study Arms (1)

Hypertensive patients

Patients having undergone a blood pressure assessment during hospitalization in the Fédération de Cardiologie at Hôpital de la Croix Rousse and Hôpital Lyon Sud from January 2018 to December 2021

Other: Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements)

Interventions

Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements) OTHER

The degree of severity of the hypertension will have been previously diagnosed for each patient with the help of the blood pressure measurements, the number of antihypertensive treatments and the NT-proBNP measurement which is correlated with the left intraventricular pressure and the mass of the left ventricle. This information will be used (i) to guide the structuring of the pathology representation space during the learning phase from a sub-population (a portion of the collected database that will be used for training algorithms); (ii) to serve as an endpoint from a test sub-population (the remaining portion of the database collected).

Hypertensive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a comprehensive hypertension assessment during hospitalization in the Cardiologic Federation at Croix Rousse Hospital and Lyon Sud Hospital between January 2018 and December 2021

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Hypertension; Hypertrophy, Left Ventricular

Interventions

Arterial Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

PierreYves COURAND, MD

CONTACT

(+33) 04 78 86 57 37; pierre-yves.courand@chu-lyon.fr

Fatou LANGEVIN

CONTACT

(+33) 04 72 07 28 65; fatou.langevin@chu-lyon.fr

Study Design

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

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: November 8, 2024
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

FR (1)