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

AHEPA University Hospital

Status: Completed

Conditions: Ambulatory Blood Pressure Monitoring; Arterial Stiffness

Treatments: Drug: Olmesartan; Drug: Chlorthalidone

Study type: Interventional

Funder types: Other

Identifiers

NCT03560804

100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Olmesartan

Active Comparator group

Description:

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

Treatment:

Drug: Olmesartan

Chlorthalidone

Active Comparator group

Description:

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

Treatment:

Drug: Chlorthalidone