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

NCT ID: NCT02346695

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-02-28

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).

Conditions

Arterial Hypertension

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Hypertensives

Untreated consecutive patients with newly diagnosed essential hypertension

No interventions assigned to this group

Controls

Normotensive individuals

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Ignatios Ikonomidis

Assistant Professor in Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignatios Ikonomidis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, Attikon Hospital, University of Athens, Greece

Helen Triantafyllidi, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, Attikon Hospital, University of Athens, Greece

John Lekakis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, Attikon Hospital, University of Athens, Greece

Locations

"Attikon" University General Hospital

Haidari, Athens, Attica, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Ignatios Ikonomidis, MD

Role: CONTACT

00302105831264

Facility Contacts

Ignatios Ikonomidis, MD

Role: primary

0030210583164

References

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.

Reference Type: DERIVED

PMID: 31898757 (View on PubMed)

Other Identifiers

214/19-6-12

Identifier Type: -

Identifier Source: org_study_id