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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482364
First Posted: November 30, 2011
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hemo Sapiens, Inc.
  Purpose
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.

Condition Intervention Phase
Hypertension Device: Integrated hemodynamic management (IHM) - HOTMAN System Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem

Further study details as provided by Hemo Sapiens, Inc.:

Primary Outcome Measures:
  • Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up. [ Time Frame: baseline and after 6 months of treatment ]
    Absolute change in daytime SBP, under ambulatory conditions (ABPM) after 6 months follow-up.


Secondary Outcome Measures:
  • The percentage of normalization of SBP (<135 mmHg) at ABPM [ Time Frame: baseline and after 6 months of treatment ]
    The percentage of normalization of SBP (<135 mmHg) at ABPM

  • The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM [ Time Frame: baseline and after 6 months of treatment ]
    The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM

  • Rate of side effects [ Time Frame: from baseline to 6 months of treatment ]
    Rate of side effects

  • The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP [ Time Frame: baseline and after 6 months of treatment ]
    The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP


Enrollment: 183
Study Start Date: October 2011
Study Completion Date: January 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HOTMAN-driven therapeutic approach arm
"Hotman-driven" therapeutic approach arm(group IHM) will receive treatment according to the results of the HOTMAN® System.
Device: Integrated hemodynamic management (IHM) - HOTMAN System
Therapeutic approach according to HOTMAN System measurement(ICG)results .
Placebo Comparator: Control arm
Control arm will receive usual antihypertensive care according to the 2007 ESH Guidelines.
Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System
Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.

Detailed Description:

Early BP control in hypertensives guarantees the best prevention of cardiovascular events on the long term (2007 ESH-ESC Guidelines on the Management of Hypertension; VALUE study). However, in spite of education efforts and antihypertensive drugs, blood pressure control rates remain low. The most common cause of uncontrolled BP is inadequate pharmacological treatment, because the selection of antihypertensive agents is often done independently of the hemodynamic status of the patient (volemia, peripheral resistance, cardiac inotropy, heart rate).

Several studies confirmed the value of using impedance cardiography (ICG)-derived hemodynamic data as an adjunct to therapeutic decision-making in the treatment of hypertension.

Working hypothesis: when it is possible to assess the hemodynamic status, and select accordingly the most appropriate pharmacological class of antihypertensive treatment, BP reduction occurs to a greater extent and more rapidly.

In the present study an integrated therapeutic approach (IHM-Integrated Hemodynamic Management)was applied, aiming at detecting permanent vasoconstriction and/or hypervolemia and/or hyperinotropy through the HOTMAN System, in order to select the most appropriate antihypertensive drugs.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients of either sex presenting with essential hypertension
  • having sustained hypertension both at office BP (SBP>140 mmHg) and at ABPM (SBP>135 mmHg daytime)
  • treated with 2 to 4 antihypertensive drugs
  • aged ≥ 18 and ≤ 75 years
  • after signature of the Informed Consent Form (ICF)

Exclusion Criteria:

  • pregnant or lactating female
  • type 1 diabetes
  • patients with pacemaker (ventricular/dual chamber)
  • Severe aortic insufficiency
  • severe hypertension (SBP ≥ 180 mmHg and/or DBP ≥110 mmHg)
  • resistant hypertension requiring at least 5 antihypertensive drugs
  • secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushing's syndrome
  • serious disorders which may limit the ability to evaluate the efficacy or safety of the protocol, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic (criteria for metabolic syndrome), haematological, oncological, neurological, or psychiatric diseases
  • history of the following pathologies within the last 6 months:
  • myocardial infarction
  • unstable angina pectoris
  • percutaneous coronary intervention
  • bypass surgery
  • congestive heart failure stage III-IV
  • left branch bundle block
  • atrial fibrillation
  • hypertensive encephalopathy
  • stroke
  • extreme obesity (BMI > 35)
  • previously enrolled subjects
  • alcohol or drug abuse in the past 2 years
  • planned hospitalization during the study period
  • participation in any other clinical study within 30 days prior to screening visit
  Contacts and Locations
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): NCT01482364


Locations
Estonia
Tallinn Hypertension Excellence Centre
Tallin, Estonia
France
Hôpital européen Georges Pompidou
Paris, France
Italy
Milano Hypertension Excellence Center
Milano, Italy
Norway
University of Oslo, Ullevaal Hospital
Oslo, Norway
Poland
Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk
Gdansk, Poland
Sponsors and Collaborators
Hemo Sapiens, Inc.
Investigators
Principal Investigator: Stephane Laurent Hopital europeen Georges Pompidou
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hemo Sapiens, Inc.
ClinicalTrials.gov Identifier: NCT01482364     History of Changes
Other Study ID Numbers: HS-01-2011
First Submitted: November 28, 2011
First Posted: November 30, 2011
Last Update Posted: March 24, 2015
Last Verified: November 2011

Keywords provided by Hemo Sapiens, Inc.:
HOTMAN System
Hemodynamic integrated management