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Association Between Left Ventricular Deformation and Aerobic Exercise Capacity in Untreated Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT02346695
Recruitment Status : Unknown
Verified January 2015 by Ignatios Ikonomidis, University of Athens.
Recruitment status was:  Recruiting
First Posted : January 27, 2015
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

Study Description
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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

Condition or disease
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).
Study Design
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Study Type : Observational
Estimated Enrollment : 480 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Vascular and Biochemical Determinants of Left Ventricular Deformation and Twisting-untwisting and Their Interrelation With Aerobic Exercise Capacity in Untreated Arterial Hypertension
Study Start Date : June 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Hypertensives
Untreated consecutive patients with newly diagnosed essential hypertension
Controls
Normotensive individuals


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Myocardial deformation in hypertensive and normotensive subjects [ Time Frame: Baseline ]
    Longitundinal, circumferential and radial strain-strain rate were measured by speckle tracking imaging

  3. 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 Outcome Measures :
  1. Collagen synthesis in hypertensive and normotensive subjects [ Time Frame: Baseline ]
    Blood levels of N-terminal procollagen type-III propeptide , carboxy-terminal propeptide and telopeptide of procollagen type-1, representing cardiac extracellular matrix turnover were measured in patients with untreated arterial hypertension and normotensive subjects

  2. Inflammation in hypertensive and normotensive subjects [ Time Frame: Baseline ]
    Transforming growth factor b-1, metalloproteinase-9, soluble angiotensin converting enzyme blood levels were measured in patients with untreated arterial hypertension and normotensive subjects

  3. Neurohumoral activation in hypertensive and normotensive subjects [ Time Frame: Baseline ]
    N-terminal pro-brain natriuretic peptide blood levels were measured in patients with untreated arterial hypertension and normotensive subjects

  4. Exercise capacity in hypertensive subjects [ Time Frame: Baseline ]
    Peak oxygen consumption during cardiopulmonary exercise test was measured in patients with untreated arterial hypertension


Biospecimen Retention:   Samples Without DNA
Plasma in serum for fibrosis and inflammatory markers

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
320 ntreated consecutive patients with newly diagnosed essential hypertension and 160 normotensive individuals
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346695


Contacts
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Contact: Ignatios Ikonomidis, MD 00302105831264

Locations
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Greece
"Attikon" University General Hospital Recruiting
Haidari, Athens, Attiki, Greece, 12462
Contact: Ignatios Ikonomidis, MD    0030210583164      
Principal Investigator: Ignatios Ikonomidis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis, MD 2nd Cardiology Department, Attikon Hospital, University of Athens, Greece
Principal Investigator: Helen Triantafyllidi, MD 2nd Cardiology Department, Attikon Hospital, University of Athens, Greece
Principal Investigator: John Lekakis, MD 2nd Cardiology Department, Attikon Hospital, University of Athens, Greece
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ignatios Ikonomidis, Assistant Professor in Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT02346695    
Other Study ID Numbers: 214/19-6-12
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015
Keywords provided by Ignatios Ikonomidis, University of Athens:
LV deformation
Endothelial glycocalyx
Coronary flow reserve
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases