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

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.

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.

Study Overview

• Status: Completed
• Conditions: Arterial Stiffness; Ambulatory Blood Pressure Monitoring
• Intervention / Treatment: Drug: Olmesartan; Drug: Chlorthalidone

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54635
    • Hypertension Excellence Center, AHEPA University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Olmesartan; ARB administration (OLMESARTAN) at a starting dose and titrating at 15 weeks according to reach blood pressure target	Drug: Olmesartan; Administration of olmesartan at starting dose and titrating in order to reach the target blood pressure.; Other Names: Olartan
Active Comparator: Chlorthalidone; Diuretic administration (chlorthalidone) at a starting dose and titrating at 15 weeks according to reach blood pressure target	Drug: Chlorthalidone; Administration of chlorthalidone at starting dose and titrating in order to reach the target blood pressure.; Other Names: Hygroton

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity	Measured by Sphygmocor devive	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic vascular resistance	Measured by impendance cardiography	12 months
Ambulatory blood pressure	Daytime and nighttime systolic and diastolic blood pressure	12 months

Collaborators and Investigators

• Sponsor: AHEPA University Hospital
• Investigators: Principal Investigator: Zebekakis Pantelis, Professor, Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2014
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): September 15, 2017

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: hemodynamics; olmesartan; chlorthalidone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Olmesartan; Chlorthalidone
• Other Study ID Numbers: 100