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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOTMAN-driven therapeutic approach arm | Experimental | "Hotman-driven" therapeutic approach arm(group IHM) will receive treatment according to the results of the HOTMAN® System. |
|
| Control arm | Placebo Comparator | Control arm will receive usual antihypertensive care according to the 2007 ESH Guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated hemodynamic management (IHM) - HOTMAN System | Device | Therapeutic approach according to HOTMAN System measurement(ICG)results . |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephane Laurent | Hopital europeen Georges Pompidou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallinn Hypertension Excellence Centre | Tallinn | Estonia | ||||
| Hôpital européen Georges Pompidou |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26485460 | Derived | 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. |
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| Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System | Device | Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results. |
|
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 |
| 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 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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