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临床试验/NCT06190756
NCT06190756已完成不适用

Effect of Intra-cardiac Hydrostatic Pressure Gradient in Cardiac Filling and Ejection

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Heart rythme

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Affiliated to the social security system
  • Patient informed of the study and having signed an informed consent form
  • Type 1 diabetes for at least 10 years followed at Caen University Hospital, equipped with a continous glucose monitoring system

排除标准

  • Trained athletes (≥ 6 hours of sustained physical exercise >70% VO2max per week for > 6 months)
  • Chronic cardiovascular disease or cardiovascular treatment
  • Personal history of chemotherapy and/or thoracic radiotherapy
  • Cerebral and/or spinal disease
  • Inclusion of the subject in another biomedical research protocol of interventional type (during the study or in the 3 months prior to inclusion)
  • Pregnant, breast-feeding or parturient women
  • Adults under legal protection (guardianship, curators) or unable to express their consent or deprived of their freedom

研究组 & 干预措施

T1 Diabetic group

Experimental

Group with diabetic patients

干预措施: Cardiovascular and Baroreflex stimulation by Tilting (Other)

T1 Diabetic group

Experimental

Group with diabetic patients

干预措施: Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure (Other)

Healthy Control Group

Other

Control group with healthy participants

干预措施: Cardiovascular and Baroreflex stimulation by Tilting (Other)

Healthy Control Group

Other

Control group with healthy participants

干预措施: Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure (Other)

结局指标

主要结局

Heart rythme

时间窗: baseline, during the intervention

continuous electrocardiogram monitoring for assessing the variation of heart frequency

Arterial blood pressure

时间窗: baseline, during the intervention

continuous central arterial pressure monitoring using Finapress

thoracic Impedancemetry

时间窗: baseline, during the intervention

estimation of body fluid variation as a surrogate of prelaod

Echocardiography

时间窗: baseline, during the intervention

non invasive diastolic intraventricular pressure gradient

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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