NCT03560804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

January 15, 2015

Last Update Submit

June 15, 2018

Conditions

Arterial StiffnessAmbulatory Blood Pressure Monitoring

Keywords

olmesartanchlorthalidonehemodynamics

Outcome Measures

Primary Outcomes (1)

  • Pulse wave velocity

    Measured by Sphygmocor devive

    12 weeks

Secondary Outcomes (2)

  • Systemic vascular resistance

    12 months

  • Ambulatory blood pressure

    12 months

Study Arms (2)

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

OlmesartanDRUG

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

Also known as: Olartan
Olmesartan
ChlorthalidoneDRUG

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

Also known as: Hygroton
Chlorthalidone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Secondary Hypertension
  • rd 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypertension Excellence Center, AHEPA University Hospital

Thessaloniki, 54635, Greece

Location

MeSH Terms

Interventions

olmesartanChlorthalidone

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Zebekakis Pantelis, Professor

    Hypertension Excellence Center, 1st Department of Internal Medicine, AHEPA University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral researcher

Study Record Dates

First Submitted

January 15, 2015

First Posted

June 18, 2018

Study Start

November 10, 2014

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

June 18, 2018

Record last verified: 2018-06

Locations

GR(1)