NCT02346695

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

2.6 years

First QC Date

January 15, 2015

Last Update Submit

January 20, 2015

Conditions

Arterial Hypertension

Keywords

LV deformationEndothelial glycocalyxCoronary flow reserve

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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 Arms (2)

Hypertensives

Untreated consecutive patients with newly diagnosed essential hypertension

Controls

Normotensive individuals

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • untreated patients with newly diagnosed essential hypertension
  • normotensive subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Attikon" University General Hospital

Haidari, Athens, Attica, 12462, Greece

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31898757DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma in serum for fibrosis and inflammatory markers

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatios Ikonomidis, MD

CONTACT

00302105831264

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Cardiology

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 27, 2015

Study Start

June 1, 2012

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

GR(1)