Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs

NCT ID: NCT03560804

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-10

Study Completion Date

2017-09-15

Brief Summary

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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

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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.

Conditions

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Arterial Stiffness Ambulatory Blood Pressure Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Olmesartan

ARB administration (OLMESARTAN) at a starting dose and titrating at 15 weeks according to reach blood pressure target

Group Type ACTIVE_COMPARATOR

Olmesartan

Intervention Type DRUG

Administration of olmesartan at starting dose and titrating in order to reach the target blood pressure.

Chlorthalidone

Diuretic administration (chlorthalidone) at a starting dose and titrating at 15 weeks according to reach blood pressure target

Group Type ACTIVE_COMPARATOR

Chlorthalidone

Intervention Type DRUG

Administration of chlorthalidone at starting dose and titrating in order to reach the target blood pressure.

Interventions

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Olmesartan

Administration of olmesartan at starting dose and titrating in order to reach the target blood pressure.

Intervention Type DRUG

Chlorthalidone

Administration of chlorthalidone at starting dose and titrating in order to reach the target blood pressure.

Intervention Type DRUG

Other Intervention Names

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Olartan Hygroton

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Secondary Hypertension
* 3rd grade of Arterial Hypertension
* Chronic renal failure
* Diabetes Mellitus
* Sleep apnea syndrome
* Chronic or acute inflammatory diseases
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AHEPA University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maria Pikilidou, MD, MSc, PhD

Post-doctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zebekakis Pantelis, Professor

Role: PRINCIPAL_INVESTIGATOR

Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital

Locations

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Hypertension Excellence Center, AHEPA University Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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100

Identifier Type: -

Identifier Source: org_study_id

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