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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Integrated hemodynamic management (IHM) - HOTMAN System; Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System

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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 3

Contacts and Locations

Study Locations

• Estonia
  • Tallin, Estonia
    • Tallinn Hypertension Excellence Centre
• France
  • Paris, France
    • Hôpital Européen Georges Pompidou
• Italy
  • Milano, Italy
    • Milano Hypertension Excellence Center
• Norway
  • Oslo, Norway
    • University of Oslo, Ullevaal Hospital
• Poland
  • Gdansk, Poland
    • Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up.	Absolute change in daytime SBP, under ambulatory conditions (ABPM) after 6 months follow-up.	baseline and after 6 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of normalization of SBP (<135 mmHg) at ABPM	The percentage of normalization of SBP (<135 mmHg) at ABPM	baseline and after 6 months of treatment
The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM	The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM	baseline and after 6 months of treatment
Rate of side effects	Rate of side effects	from baseline to 6 months of treatment
The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP	The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP	baseline and after 6 months of treatment

Collaborators and Investigators

• Sponsor: Hemo Sapiens, Inc.
• Investigators: Principal Investigator: Stephane Laurent, Hôpital Européen Georges Pompidou

Publications and helpful links

General Publications

• Fadl Elmula FE, Rebora P, Talvik A, Salerno S, Miszkowska-Nagorna E, Liu X, Heinpalu-Kuum M, Comotti T, Larstorp AC, Rostrup M, Swierblewska E, Valsecchi MG, Kjeldsen SE, Viigimaa M, Narkiewicz K, Parati G, Laurent S; BEtter control of blood pressure in hypertensive pAtients monitored Using the HOTMAN sYstem (BEAUTY) Study Investigators. A randomized and controlled study of noninvasive hemodynamic monitoring as a guide to drug treatment of uncontrolled hypertensive patients. J Hypertens. 2015 Dec;33(12):2534-45. doi: 10.1097/HJH.0000000000000749.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (ESTIMATE): November 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: HOTMAN System; Hemodynamic integrated management
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HS-01-2011