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

Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02346695
• Other study ID #: 214/19-6-12
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2015
• Last updated: January 20, 2015
• Start date: June 2012
• Est. completion date: February 2015

Study information

• Verified date: January 2015
• Source: University of Athens
• Contact: Ignatios Ikonomidis, MD
• Phone: 00302105831264
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• untreated patients with newly diagnosed essential hypertension

• normotensive subjects

Exclusion Criteria:

• history of diabetes

• familiar hyperlipidemia

• coronary CAD

• cardiomyopathy

• chronic pulmonary disease

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Locations

Country	Name	City	State
Greece	"Attikon" University General Hospital	Haidari, Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular function in hypertensive and normotensive subjects	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	Baseline	No
Primary	Myocardial deformation in hypertensive and normotensive subjects	Longitundinal, circumferential and radial strain-strain rate were measured by speckle tracking imaging	Baseline	No
Primary	Left ventricular twisting-untwisting in hypertensive and normotensive subjects	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	Baseline	No
Secondary	Collagen synthesis in hypertensive and normotensive subjects	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	Baseline	No
Secondary	Inflammation in hypertensive and normotensive subjects	Transforming growth factor b-1, metalloproteinase-9, soluble angiotensin converting enzyme blood levels were measured in patients with untreated arterial hypertension and normotensive subjects	Baseline	No
Secondary	Neurohumoral activation in hypertensive and normotensive subjects	N-terminal pro-brain natriuretic peptide blood levels were measured in patients with untreated arterial hypertension and normotensive subjects	Baseline	No
Secondary	Exercise capacity in hypertensive subjects	Peak oxygen consumption during cardiopulmonary exercise test was measured in patients with untreated arterial hypertension	Baseline	No