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Completed

NCT Number: NCT03560804

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

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.

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Key information

Conditions

Arterial Stiffness Ambulatory Blood Pressure Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hypertension Excellence Center, AHEPA University Hospital

Thessaloniki, 54635, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olmesartan

Drug

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

Other names: Olartan

Chlorthalidone

Drug

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

Other names: Hygroton

Primary outcomes

  1. Pulse wave velocity

    Time frame: 12 weeks

    Measured by Sphygmocor devive

Secondary outcomes

  1. Systemic vascular resistance

    Time frame: 12 months

    Measured by impendance cardiography

  2. Ambulatory blood pressure

    Time frame: 12 months

    Daytime and nighttime systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Registry information

Official study title

Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect. Comparison Between an ATII Receptor Antagonist and a Diuretic.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2018
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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