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

Study Overview
=================
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.

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

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Integrated hemodynamic management (IHM) - HOTMAN System
* Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOTMAN-driven therapeutic approach arm<br>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<br>* Therapeutic approach according to HOTMAN System measurement(ICG)results .<br>|
| Placebo Comparator: Control arm<br>Control arm will receive usual antihypertensive care according to the 2007 ESH Guidelines. | Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System<br>* Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HOTMAN System, Hemodynamic integrated management