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

NCT ID: NCT01482364

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-01-31

Brief 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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HOTMAN-driven therapeutic approach arm

"Hotman-driven" therapeutic approach arm(group IHM) will receive treatment according to the results of the HOTMAN® System.

Group Type: EXPERIMENTAL

Integrated hemodynamic management (IHM) - HOTMAN System

Intervention Type: DEVICE

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

Control arm

Control arm will receive usual antihypertensive care according to the 2007 ESH Guidelines.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

Integrated hemodynamic management (IHM) - HOTMAN System

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hemo Sapiens, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephane Laurent

Role: PRINCIPAL_INVESTIGATOR

Hopital europeen Georges Pompidou

Locations

Tallinn Hypertension Excellence Centre

Tallinn, , Estonia

Hôpital européen Georges Pompidou

Paris, , France

Milano Hypertension Excellence Center

Milan, , Italy

University of Oslo, Ullevaal Hospital

Oslo, , Norway

Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk

Gdansk, , Poland

Countries

Estonia; France; Italy; Norway; Poland

References

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.

Reference Type: DERIVED

PMID: 26485460 (View on PubMed)

Other Identifiers

HS-01-2011

Identifier Type: -

Identifier Source: org_study_id