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Trial record 77 of 134 for:    OLMESARTAN

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

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ClinicalTrials.gov Identifier: NCT03560804
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Pikilidou, MD, MSc, PhD, AHEPA University Hospital

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
Arterial Stiffness Ambulatory Blood Pressure Monitoring Drug: Olmesartan Drug: Chlorthalidone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : November 10, 2014
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Hygroton




Primary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: 12 weeks ]
    Measured by Sphygmocor devive


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560804


Locations
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Greece
Hypertension Excellence Center, AHEPA University Hospital
Thessaloniki, Greece, 54635
Sponsors and Collaborators
AHEPA University Hospital
Investigators
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Principal Investigator: Zebekakis Pantelis, Professor Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital

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Responsible Party: Maria Pikilidou, MD, MSc, PhD, Post-doctoral researcher, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT03560804     History of Changes
Other Study ID Numbers: 100
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Keywords provided by Maria Pikilidou, MD, MSc, PhD, AHEPA University Hospital:
olmesartan
chlorthalidone
hemodynamics
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Chlorthalidone
Diuretics
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators