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

Not Applicable

Completed

• Conditions: Ambulatory Blood Pressure Monitoring; Arterial Stiffness
• Interventions: Drug: Olmesartan; Drug: Chlorthalidone

• Registration Number: NCT03560804
• Lead Sponsor: AHEPA University Hospital

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.

Study Timeline

• Study Start: 2014-11-10
• Study First Submitted: 2015-01-15
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-15
• Last Update Submitted: 2018-06-15
• Study First Posted: 2018-06-18
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olmesartan	Olmesartan	ARB administration (OLMESARTAN) at a starting dose and titrating at 15 weeks according to reach blood pressure target
Chlorthalidone	Chlorthalidone	Diuretic administration (chlorthalidone) at a starting dose and titrating at 15 weeks according to reach blood pressure target

Primary Outcome Measures

Name	Time	Method
Pulse wave velocity	12 weeks	Measured by Sphygmocor devive

Secondary Outcome Measures

Name	Time	Method
Systemic vascular resistance	12 months	Measured by impendance cardiography
Ambulatory blood pressure	12 months	Daytime and nighttime systolic and diastolic blood pressure

Trial Locations

Locations (1)

Hypertension Excellence Center, AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece