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

Sponsor
AHEPA University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03560804
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
34.2
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect. Comparison Between an ATII Receptor Antagonist and a Diuretic.
Actual Study Start Date :
Nov 10, 2014
Actual Primary Completion Date :
Sep 15, 2017
Actual Study Completion Date :
Sep 15, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pulse wave velocity [12 weeks]

      Measured by Sphygmocor devive

    Secondary Outcome Measures

    1. Systemic vascular resistance [12 months]

      Measured by impendance cardiography

    2. Ambulatory blood pressure [12 months]

      Daytime and nighttime systolic and diastolic blood pressure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hypertension Excellence Center, AHEPA University Hospital Thessaloniki Greece 54635

    Sponsors and Collaborators

    • AHEPA University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria Pikilidou, MD, MSc, PhD, Post-doctoral researcher, AHEPA University Hospital
    ClinicalTrials.gov Identifier:
    NCT03560804
    Other Study ID Numbers:
    • 100
    First Posted:
    Jun 18, 2018
    Last Update Posted:
    Jun 18, 2018
    Last Verified:
    Jun 1, 2018
    Keywords provided by Maria Pikilidou, MD, MSc, PhD, Post-doctoral researcher, AHEPA University Hospital
    olmesartan
    chlorthalidone
    hemodynamics
    Additional relevant MeSH terms:
    Olmesartan
    Chlorthalidone

    Study Results

    No Results Posted as of Jun 18, 2018