Arterial HypertensionNCT02346695
Association Between Left Ventricular Deformation and Aerobic Exercise Capacity in Untreated Arterial Hypertension
An observational study of Arterial Hypertension, run by University of Athens at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Hypertension
- How many people
- 480 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 320 ntreated consecutive patients with newly diagnosed essential hypertension and 160 normotensive individuals
Who may be able to join
- untreated patients with newly diagnosed essential hypertension
- normotensive subjects
Who cannot join
- history of diabetes
- familiar hyperlipidemia
- coronary CAD
- cardiomyopathy
- chronic pulmonary disease
Trial locations and contacts
1 site in 1 country.
Ignatios Ikonomidis, MD contact
Greece1 site, 1 recruiting
- Recruiting
"Attikon" University General Hospital
Haidari, Athens, Attica, 12462
Ignatios Ikonomidis, MD, 0030210583164
Ignatios Ikonomidis, MD
About this study
Official title: 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
Read the detailed description
The investigators plan to examine 320 untreated hypertensives and 160 controls. They will measure:
- the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus
- the coronary flow reserve (CFR) at baseline and after adenosine infusion (140 μg x kg-1 x min-1) by Doppler echocardiography
- 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
- 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
- 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).
- 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
- 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
- Keywords
- LV deformation, Endothelial glycocalyx, Coronary flow reserve
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensives | Untreated consecutive patients with newly diagnosed essential hypertension | |
| Controls | Normotensive individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Myocardial deformation in hypertensive and normotensive subjects
Longitundinal, circumferential and radial strain-strain rate were measured by speckle tracking imaging
Measured: 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
Measured: Baseline
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: Baseline
Exercise capacity in hypertensive subjects
Peak oxygen consumption during cardiopulmonary exercise test was measured in patients with untreated arterial hypertension
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJun 2012
- Primary completionJan 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, MD, Principal investigator, 2nd Cardiology Department, Attikon Hospital, University of Athens, GreeceHelen Triantafyllidi, MD, Principal investigator, 2nd Cardiology Department, Attikon Hospital, University of Athens, GreeceJohn Lekakis, MD, Principal investigator, 2nd Cardiology Department, Attikon Hospital, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346695
- Sponsor's protocol ID
- 214/19-6-12
- Status last verified
- Jan 2015
- First submitted
- 15 Jan 2015
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31898757
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular and Biochemical Determinants of Left Ventricular Deformation and Twisting-untwisting and Their Interrelation With Aerobic Exercise Capacity in Untreated Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02346695
- Acronym / sponsor ID
- 214/19-6-12
- Conditions
- Arterial Hypertension
- Keywords
- LV deformation, Endothelial glycocalyx, Coronary flow reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus
- the coronary flow reserve (CFR) at baseline and after adenosine infusion (140 μg x kg-1 x min-1) by Doppler echocardiography
- 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
- 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
- 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).
- 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
- 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertensives | – | –Untreated consecutive patients with newly diagnosed essential hypertension |
| Controls | – | –Normotensive individuals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 320 ntreated consecutive patients with newly diagnosed essential hypertension and 160 normotensive individuals
Key inclusion criteria (2 listed)
- untreated patients with newly diagnosed essential hypertension
- normotensive subjects
Key exclusion criteria (5 listed)
- history of diabetes
- familiar hyperlipidemia
- coronary CAD
- cardiomyopathy
- chronic pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Myocardial deformation in hypertensive and normotensive subjects
Time frame: Baseline
Longitundinal, circumferential and radial strain-strain rate were measured by speckle tracking imaging
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
4 secondary outcomes
Collagen synthesis in hypertensive and normotensive subjects
Time frame: Baseline
Inflammation in hypertensive and normotensive subjects
Time frame: Baseline
Neurohumoral activation in hypertensive and normotensive subjects
Time frame: Baseline
Exercise capacity in hypertensive subjects
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Derived from this study: PubMed 31898757Tzortzis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignatios Ikonomidis, MD contact
Ignatios Ikonomidis, MD principal investigator
2nd Cardiology Department, Attikon Hospital, University of Athens, Greece
Helen Triantafyllidi, MD principal investigator
2nd Cardiology Department, Attikon Hospital, University of Athens, Greece
John Lekakis, MD principal investigator
2nd Cardiology Department, Attikon Hospital, University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignatios Ikonomidis, MD (00302105831264), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular function in hypertensive and normotensive subjects (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.