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BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem

NCT01482364 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2015-03-24

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that monitoring hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) improves the control of systolic blood pressure (SBP) at ambulatory blood pressure monitoring (ABPM) in hypertensive patients, as compared to classical drug selection (i.e. without IHM) during a 6 months intensive treatment program.

Conditions

Interventions

DEVICE

Integrated hemodynamic management (IHM) - HOTMAN System

Therapeutic approach according to HOTMAN System measurement(ICG)results .

DEVICE

Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System

Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.

Sponsors & Collaborators

  • Hemo Sapiens, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephane Laurent · Hopital europeen Georges Pompidou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-06-30
Completion
2014-01-31

Countries

  • Estonia
  • France
  • Italy
  • Norway
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01482364 on ClinicalTrials.gov