Use of Impedance Cardiography and Applanation Tonometry f... | NCT03560804

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

NCT03560804

Sponsor

AHEPA University Hospital

Status

Completed

Last Update Posted

Jun 18, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Arterial Stiffness
Ambulatory Blood Pressure Monitoring

Interventions

Olmesartan
Chlorthalidone

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2014Actual

Primary Completion Date

Sep 15, 2017Actual

Completion Date

Sep 15, 2017Actual

First Submitted Date

Jan 15, 2015

First Submission Date that Met QC Criteria

Jun 15, 2018

First Posted Date

Jun 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2018

Last Update Posted Date

Jun 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Pikilidou, MD, MSc, PhD, Post-doctoral researcher, AHEPA University HospitalPrincipal Investigator

Lead Sponsor

AHEPA University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olmesartan	Active Comparator	ARB administration (OLMESARTAN) at a starting dose and titrating at 15 weeks according to reach blood pressure target	Drug: Olmesartan
Chlorthalidone	Active Comparator	Diuretic administration (chlorthalidone) at a starting dose and titrating at 15 weeks according to reach blood pressure target	Drug: Chlorthalidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olmesartan	Drug	Administration of olmesartan at starting dose and titrating in order to reach the target blood pressure.	Olmesartan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulse wave velocity	Measured by Sphygmocor devive	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Systemic vascular resistance	Measured by impendance cardiography	12 months
Ambulatory blood pressure	Daytime and nighttime systolic and diastolic blood pressure

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zebekakis Pantelis, Professor	Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hypertension Excellence Center, AHEPA University Hospital		Thessaloniki		54635	Greece

Intervention Browse Module

MeSH Terms

ID	Term
C437965	olmesartan
D002752	Chlorthalidone

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

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Browse Branches

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