Arterial StiffnessNCT03560804
Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs
A study testing Olmesartan and Chlorthalidone in people with Arterial Stiffness and Ambulatory Blood Pressure Monitoring, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Stiffness, Ambulatory Blood Pressure Monitoring
- What is being tested?
- Olmesartan and Chlorthalidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 10 Nov 2014to 15 Sep 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Drug naive patients with 1st or 2nd grade Arterial Hypertension according to the ESH/ESC guidelines 2013
- The patient has signed the concent form
Who cannot join
- Secondary Hypertension
- 3rd grade of Arterial Hypertension
- Chronic renal failure
- Diabetes Mellitus
- Sleep apnea syndrome
- Chronic or acute inflammatory diseases
Show all 16Show fewer
- Stroke, myocardial infarction, angina pectoris in the past 6 months
- Heart failure
- Liver disease
- Neoplasms
- Pregnancy
- Valvular Heart disease
- Heigt < 120cm or > 230cm, Weight <30kg or >155kg
- Heart Arrhytmias
- Artificial cardiac pacemaker
- Hemodymanic unstable patients
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hypertension Excellence Center, AHEPA University Hospital
Thessaloniki, 54635
About this study
Official title: Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect. Comparison Between an ATII Receptor Antagonist and a Diuretic.
The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.
The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.
Read more
The other basic aim of the study is to determine whether there is a difference (>6mmHg) between the two drugs regarding the reduction of the mean 24hour blood pressure and the effect of them on the hemodynamic parameters.
The hemodynamic parameters that will be measured by applanation tonometry are augmentation index, central blood pressure and pulse wave velocity.
The hemodynamic parameters that will be measured by impedance cardiography are cardiac index, thoracic fluid content index, systemic vascular resistance index and others.
Read the detailed description
The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.
The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.
- Being tested
- Olmesartan, Chlorthalidone
- Keywords
- olmesartan, chlorthalidone, hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlmesartanDrug
Also called Olartan
Administration of olmesartan at starting dose and titrating in order to reach the target blood pressure.
ChlorthalidoneDrug
Also called Hygroton
Administration of chlorthalidone at starting dose and titrating in order to reach the target blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Olmesartan | Active comparator | ARB administration (OLMESARTAN) at a starting dose and titrating at 15 weeks according to reach blood pressure target Receives: Drug: Olmesartan |
| Chlorthalidone | Active comparator | Diuretic administration (chlorthalidone) at a starting dose and titrating at 15 weeks according to reach blood pressure target Receives: Drug: Chlorthalidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Measured by Sphygmocor devive
Measured: 12 weeks
Secondary outcomes (2)
Systemic vascular resistance
Measured by impendance cardiography
Measured: 12 months
Ambulatory blood pressure
Daytime and nighttime systolic and diastolic blood pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start10 Nov 2014
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Pikilidou, MD, MSc, PhD, AHEPA University Hospital
- Investigators
- Zebekakis Pantelis, Professor, Principal investigator, Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560804
- Sponsor's protocol ID
- 100
- Status last verified
- Jun 2018
- First submitted
- 15 Jan 2015
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect. Comparison Between an ATII Receptor Antagonist and a Diuretic.
- ClinicalTrials.gov ID
- NCT03560804
- Acronym / sponsor ID
- 100
- Keywords
- olmesartan, chlorthalidone, hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2014 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 18 Jun 2018 (actual)
- 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.
The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.
The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.
The other basic aim of the study is to determine whether there is a difference (>6mmHg) between the two drugs regarding the reduction of the mean 24hour blood pressure and the effect of them on the hemodynamic parameters.
The hemodynamic parameters that will be measured by applanation tonometry are augmentation index, central blood pressure and pulse wave velocity.
The hemodynamic parameters that will be measured by impedance cardiography are cardiac index, thoracic fluid content index, systemic vascular resistance index and others.
Detailed description
The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics.
The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olmesartan | Active comparator | Drug: OlmesartanARB administration (OLMESARTAN) at a starting dose and titrating at 15 weeks according to reach blood pressure target |
| Chlorthalidone | Active comparator | Drug: ChlorthalidoneDiuretic administration (chlorthalidone) at a starting dose and titrating at 15 weeks according to reach blood pressure target |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Drug naive patients with 1st or 2nd grade Arterial Hypertension according to the ESH/ESC guidelines 2013
- The patient has signed the concent form
Key exclusion criteria (16 listed)
- Secondary Hypertension
- 3rd grade of Arterial Hypertension
- Chronic renal failure
- Diabetes Mellitus
- Sleep apnea syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlmesartanAlso: OlartanAdministration of olmesartan at starting dose and titrating in order to reach the target blood pressure. | Drug | Olmesartan |
| ChlorthalidoneAlso: HygrotonAdministration of chlorthalidone at starting dose and titrating in order to reach the target blood pressure. | Drug | Chlorthalidone |
Primary outcome
Pulse wave velocity
Time frame: 12 weeks
Measured by Sphygmocor devive
2 secondary outcomes
Systemic vascular resistance
Time frame: 12 months
Ambulatory blood pressure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
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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.
Zebekakis Pantelis, Professor principal investigator
Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olmesartan and Chlorthalidone in people with Arterial Stiffness and Ambulatory Blood Pressure Monitoring, run by AHEPA University Hospital 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 3 inclusion and 16 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: finished, as of the sponsor's last update on 18 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.