Clinical trial NCT01482364: BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: HOTMAN System
Hemodynamic integrated management
Lead sponsor: Hemo Sapiens, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up.
timeFrame: baseline and after 6 months of treatment
Secondary outcomes:
measure: The percentage of normalization of SBP (<135 mmHg) at ABPM
timeFrame: baseline and after 6 months of treatment
measure: The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM
timeFrame: baseline and after 6 months of treatment
measure: Rate of side effects
timeFrame: from baseline to 6 months of treatment
measure: The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP
timeFrame: baseline and after 6 months of treatment
Other outcomes:
Locations:
city: Tallin
country: Estonia
facility: Tallinn Hypertension Excellence Centre
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
city: Milano
country: Italy
facility: Milano Hypertension Excellence Center
city: Oslo
country: Norway
facility: University of Oslo, Ullevaal Hospital
city: Gdansk
country: Poland
facility: Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk
Study officials:
affiliation: Hopital europeen Georges Pompidou
name: Stephane Laurent
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.