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

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

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

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 480

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Haidari, Athens, Attiki, Greece, 12462
      • Recruiting
      • "ATTIKON" University General Hospital
      • Contact: Ignatios Ikonomidis, MD; Phone Number: 0030210583164

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

320 ntreated consecutive patients with newly diagnosed essential hypertension and 160 normotensive individuals

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hypertensives; Untreated consecutive patients with newly diagnosed essential hypertension
Controls; Normotensive individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Myocardial deformation in hypertensive and normotensive subjects	Longitundinal, circumferential and radial strain-strain rate were measured by speckle tracking imaging	Baseline
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Exercise capacity in hypertensive subjects	Peak oxygen consumption during cardiopulmonary exercise test was measured in patients with untreated arterial hypertension	Baseline

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: 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

Publications and helpful links

General Publications

• Tzortzis S, Ikonomidis I, Triantafyllidi H, Trivilou P, Pavlidis G, Katsanos S, Katogiannis K, Birba D, Thymis J, Makavos G, Varoudi M, Frogoudaki A, Vrettou AR, Vlastos D, Parissis J, Lekakis J. Optimal Blood Pressure Control Improves Left Ventricular Torsional Deformation and Vascular Function in Newly Diagnosed Hypertensives: a 3-Year Follow-up Study. J Cardiovasc Transl Res. 2020 Oct;13(5):814-825. doi: 10.1007/s12265-019-09951-9. Epub 2020 Jan 2.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimate): January 27, 2015

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Coronary flow reserve; Endothelial glycocalyx; LV deformation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 214/19-6-12