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

Arterial Stiffness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560804
• Other study ID #: 100
• Status: Completed
• Phase: N/A
• Start date: November 10, 2014
• Est. completion date: September 15, 2017

Study information

• Verified date: June 2018
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Blood Pressure Monitoring
• Arterial Stiffness

Intervention

Drug:
• Olmesartan
Administration of olmesartan at starting dose and titrating in order to reach the target blood pressure.
• Chlorthalidone
Administration of chlorthalidone at starting dose and titrating in order to reach the target blood pressure.

Locations

Country	Name	City	State
Greece	Hypertension Excellence Center, AHEPA University Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave velocity	Measured by Sphygmocor devive	12 weeks
Secondary	Systemic vascular resistance	Measured by impendance cardiography	12 months
Secondary	Ambulatory blood pressure	Daytime and nighttime systolic and diastolic blood pressure	12 months