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Clinical Trials/NCT02346695
NCT02346695
Unknown
Not Applicable

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 site in 1 country480 target enrollmentJune 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arterial Hypertension
Sponsor
University of Athens
Enrollment
480
Locations
1
Primary Endpoint
Vascular function in hypertensive and normotensive subjects
Last Updated
11 years ago

Overview

Brief Summary

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

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
February 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Athens
Responsible Party
Principal Investigator
Principal Investigator

Ignatios Ikonomidis

Assistant Professor in Cardiology

University of Athens

Eligibility Criteria

Inclusion Criteria

  • untreated patients with newly diagnosed essential hypertension
  • normotensive subjects

Exclusion Criteria

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

Outcomes

Primary Outcomes

Vascular function in hypertensive and normotensive subjects

Time Frame: 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

Time Frame: Baseline

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

Left ventricular twisting-untwisting in hypertensive and normotensive subjects

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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