Clinical trial NCT03560804: Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs
Official title: Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect. Comparison Between an ATII Receptor Antagonist and a Diuretic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Stiffness
Ambulatory Blood Pressure Monitoring
Keywords: olmesartan
chlorthalidone
hemodynamics
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulse wave velocity
timeFrame: 12 weeks
Secondary outcomes:
measure: Systemic vascular resistance
timeFrame: 12 months
measure: Ambulatory blood pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Hypertension Excellence Center, AHEPA University Hospital
Study officials:
affiliation: Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital
name: Zebekakis Pantelis, Professor
role: PRINCIPAL_INVESTIGATOR
References: