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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
183
Therapeutic approach according to HOTMAN System measurement(ICG)results .
Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.
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
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.
Time frame: baseline and after 6 months of treatment
The percentage of normalization of SBP (<135 mmHg) at ABPM
The percentage of normalization of SBP (\<135 mmHg) at ABPM
Time frame: 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
Time frame: baseline and after 6 months of treatment
Rate of side effects
Rate of side effects
Time frame: 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
Time frame: baseline and after 6 months of treatment
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Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk
Gdansk, Poland