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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Hemo Sapiens, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hemo Sapiens, Inc.
ClinicalTrials.gov Identifier:
NCT01482364
First received: November 28, 2011
Last updated: December 2, 2011
Last verified: November 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP


Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: November 2012 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482364

Contacts
Contact: Tamara Movileanu, M.D. + 40 729 04 69 29 tamara.movileanu@hemosapiens.net
Contact: Ilie Lazarescu, M.D. + 40 21 334 93 57 ilie.lazarescu@hemosapiens.net

Locations
Estonia
Tallinn Hypertension Excellence Centre Recruiting
Tallin, Estonia
Contact: Margus Viigima       margus.viigimaa@regionaalhaigla.ee   
Principal Investigator: Margus Viigimaa         
France
Hôpital européen Georges Pompidou Not yet recruiting
Paris, France
Contact: Stéphane Laurent       stephane.laurent@egp.ap-hop-paris.fr   
Principal Investigator: Stephane Laurent         
Italy
Milano Hypertension Excellence Center Recruiting
Milano, Italy
Contact: Gianfranco Parati       gianfranco.parati@unimib.it   
Principal Investigator: Gianfranco Parati         
Norway
University of Oslo, Ullevaal Hospital Recruiting
Oslo, Norway
Contact: Sverre Kjeldsen         
Principal Investigator: Sverre Kjeldsen         
Poland
Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk Not yet recruiting
Gdansk, Poland
Contact: Krzysztof Narkiewicz       knark@amg.gda.pl   
Principal Investigator: Krzysztof Narkiewicz         
Sponsors and Collaborators
Hemo Sapiens, Inc.
Investigators
Principal Investigator: Stephane Laurent Hopital europeen Georges Pompidou
  More Information

No publications provided

Responsible Party: Hemo Sapiens, Inc.
ClinicalTrials.gov Identifier: NCT01482364     History of Changes
Other Study ID Numbers: HS-01-2011
Study First Received: November 28, 2011
Last Updated: December 2, 2011
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
Poland: Ethics Committee
Norway:National Committee for Medical and Health Research Ethics
Estonia: Research Ethics Committee
Italy: The Italian National Bioethics Committee

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014