Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-04 @ 1:26 AM
Study NCT ID:
NCT06190756
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2023-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Gravity on Cardiac Hemodynamics
Sponsor:
University Hospital, Caen
Organization:
Study Overview
Official Title:
Effect of Intra-cardiac Hydrostatic Pressure Gradient in Cardiac Filling and Ejection
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACUITY
Brief Summary:
The goal of this clinical trial is to define and compare pre-load dependance of the cardiac function according to the intracardiac hydrostatic gradient of pressure in healthy and diabetic populations.
Participants will undergo 4 tilt angle and 4 lower body negative pressure intensities during which cardiovascular data will be assessed and a transthoracic echography will be performed.
Participants will undergo 4 tilt angle and 4 lower body negative pressure intensities during which cardiovascular data will be assessed and a transthoracic echography will be performed.
Detailed Description:
Gravitational force affects both the cardiac mass and the thoracic compartment. However, few studies in humans have explored whether the relationship between cardiac function and load-dependence varies according to the orientation of the heart in space (e.g. between the upright and supine positions) and therefore according to gravitational stress.
Thirty-two volunteers (16 healthy subjects and 16 subjects with type I diabetes) will be included in the study. Each subject will be analysed over half a day in the Inserm COMETE laboratory. Measurements of the intra-cardiac hydrostatic pressure gradient (reflecting gravitational force) and indicators of cardiac function will be analysed by transthoracic echocardiography using dedicated post-processing software. These measurements will be compared at identical pre-load on the basis of the relationship between thoracic impedance and angle of vertical inclination using a Tilt Test on the one hand and between thoracic impedance and Lower Body Negative Pressure (LBNP) depression in the supine position on the other. In the supine position, the echocardiogram will be repeated for each subject with different levels of intensity of preload decrease by LBNP up to a maximum of -50 torr, and compared with different angles of vertical inclination head up up to +80° on the Tilt Test.
The study aims to compare the contribution of intra-cardiac hydrostatic force to cardiac filling and ejection mechanics in a population of healthy volunteers and subjects with diabetes.
The goal is to define and compare the pre-load dependence of the cardiac function indices studied according to the anatomical supine posture with zero intra-cardiac hydrostatic gradient with the standing posture during which the hydrostatic force is expressed between the cardiac base and apex. The hypothesis is that cardiac filling and ejection are improved when the longitudinal axis of the heart is anatomically oriented in the standing position compared with the supine position, by restoring the intraventricular hydrostatic pressure gradient. Comparing a group of healthy subjects with a group of subjects with diabetes will enable to assess whether the dependence of cardiac function on the orientation of the heart in space is more marked in the presence of subclinical impairment of myocardial function.
Thirty-two volunteers (16 healthy subjects and 16 subjects with type I diabetes) will be included in the study. Each subject will be analysed over half a day in the Inserm COMETE laboratory. Measurements of the intra-cardiac hydrostatic pressure gradient (reflecting gravitational force) and indicators of cardiac function will be analysed by transthoracic echocardiography using dedicated post-processing software. These measurements will be compared at identical pre-load on the basis of the relationship between thoracic impedance and angle of vertical inclination using a Tilt Test on the one hand and between thoracic impedance and Lower Body Negative Pressure (LBNP) depression in the supine position on the other. In the supine position, the echocardiogram will be repeated for each subject with different levels of intensity of preload decrease by LBNP up to a maximum of -50 torr, and compared with different angles of vertical inclination head up up to +80° on the Tilt Test.
The study aims to compare the contribution of intra-cardiac hydrostatic force to cardiac filling and ejection mechanics in a population of healthy volunteers and subjects with diabetes.
The goal is to define and compare the pre-load dependence of the cardiac function indices studied according to the anatomical supine posture with zero intra-cardiac hydrostatic gradient with the standing posture during which the hydrostatic force is expressed between the cardiac base and apex. The hypothesis is that cardiac filling and ejection are improved when the longitudinal axis of the heart is anatomically oriented in the standing position compared with the supine position, by restoring the intraventricular hydrostatic pressure gradient. Comparing a group of healthy subjects with a group of subjects with diabetes will enable to assess whether the dependence of cardiac function on the orientation of the heart in space is more marked in the presence of subclinical impairment of myocardial function.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: