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临床试验/NCT02346695
NCT02346695Unknown不适用

Vascular and Biochemical Determinants of Left Ventricular Deformation and Twisting-untwisting and Their Interrelation With Aerobic Exercise Capacity in Untreated Arterial Hypertension

University of Athens1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
480
试验地点
1
主要终点
Vascular function in hypertensive and normotensive subjects

研究概览

简要总结

Impaired myocardial deformation may determine cardiac diastolic dysfunction. The investigators will investigate the vascular determinants of myocardial deformation and twisting-untwisting and their interrelation with exercise capacity in patients with untreated arterial hypertension

详细描述

The investigators plan to examine 320 untreated hypertensives and 160 controls. They will measure:

  1. the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus
  2. the coronary flow reserve (CFR) at baseline and after adenosine infusion (140 μg x kg-1 x min-1) by Doppler echocardiography
  3. the Global Longitudinal strain and strain rate, peak twisting, the percentage changes between peak twisting and untwisting at mitral valve opening (UtwMVO), at peak (UtwPEF) and end of early LV diastolic filling (UtwEDF) by speckle tracking imaging
  4. the perfusion boundary region (PBR-micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate non invasive index of reduced endothelial glycocalyx thickness
  5. transforming growth factor (TGFb-1), metalloproteinase-9 (MMP-9), markers of collagen synthesis (N-terminal procollagen type-III propeptide , carboxy-terminal propeptide and telopeptide of procollagen type-1, representing cardiac extracellular matrix turnover) and N-terminal pro-brain natriuretic peptide (NT-proBNP) and soluble angiotensin-converting enzyme (sACE).
  6. Twenty-four hour daytime and night-time average systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rates as well as 24h-pulse pressure (PP) by means of 24h ambulatory blood pressure monitoring (ABPM) Monitoring will be carried out on the non-dominant arm using the valid recorder TONOPORT V (General Electric, Health Care, Berlin, Germany) after validation of readings against a mercury sphygmomanometer by means of a Y tube. The ABPM device will set to obtain BP readings at 15 min intervals during the day (07.00-23.00) and at 20 min intervals during the night (23.00-07.00). The patients will be instructed to attend their usual day-to-day activities but to keep still at the times of measurements. Recordings will be analysed to obtain
  7. oxygen consumption as an absolute value and in relation to body weight (VO2/Kg) and maximum work load (METS) by means of a physician-supervised maximal, symptom-limited cardiopulmonary exercise test (CPET) on a bicycle ergometer using a standard ramping protocol (Oxycon Pro system, Jaeger, Germany).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • untreated patients with newly diagnosed essential hypertension
  • normotensive subjects

排除标准

  • history of diabetes
  • familiar hyperlipidemia
  • coronary CAD
  • cardiomyopathy
  • chronic pulmonary disease

结局指标

主要结局

Vascular function in hypertensive and normotensive subjects

时间窗: Baseline

Pulse wave velocity by Complior,endothelial glycocalyx thickness by Miscroscan camera and coronary flow reserve by Doppler echocardiography were measured in hypertensive and normotensive subjects

Myocardial deformation in hypertensive and normotensive subjects

时间窗: Baseline

Longitundinal, circumferential and radial strain-strain rate were measured by speckle tracking imaging

Left ventricular twisting-untwisting in hypertensive and normotensive subjects

时间窗: Baseline

Peak twisting-untwisting ,twisting-untwisting velocity, the percentage difference between peak twisting and untwisting at mitral valve opening , peak and end of early diastolic filling of the left ventricle was measured by speckle tracking imaging

次要结局

  • Collagen synthesis in hypertensive and normotensive subjects(Baseline)
  • Inflammation in hypertensive and normotensive subjects(Baseline)
  • Neurohumoral activation in hypertensive and normotensive subjects(Baseline)
  • Exercise capacity in hypertensive subjects(Baseline)

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignatios Ikonomidis

Assistant Professor in Cardiology

University of Athens

研究点 (1)

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