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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Device: Integrated hemodynamic management (IHM) - HOTMAN System; Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System

• Registration Number: NCT01482364
• Lead Sponsor: Hemo Sapiens, Inc.

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.

Study Timeline

• Study Start: 2011-10
• Status Verified: 2011-11
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-11-30
• Primary Completion: 2013-06
• Study Completion: 2014-01
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HOTMAN-driven therapeutic approach arm	Integrated hemodynamic management (IHM) - HOTMAN System	"Hotman-driven" therapeutic approach arm(group IHM) will receive treatment according to the results of the HOTMAN® System.
Control arm	Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System	Control arm will receive usual antihypertensive care according to the 2007 ESH Guidelines.

Primary Outcome Measures

Name	Time	Method
Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up.	baseline and after 6 months of treatment	Absolute change in daytime SBP, under ambulatory conditions (ABPM) after 6 months follow-up.

Secondary Outcome Measures

Name	Time	Method
The percentage of normalization of SBP (<135 mmHg) at ABPM	baseline and after 6 months of treatment	The percentage of normalization of SBP (\<135 mmHg) at ABPM
Rate of side effects	from baseline to 6 months of treatment	Rate of side effects
The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP	baseline and after 6 months of treatment	The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP
The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM	baseline and after 6 months of treatment	The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM

Trial Locations

Locations (5)

Milano Hypertension Excellence Center; 🇮🇹 Milano, Italy

Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk; 🇵🇱 Gdansk, Poland

Tallinn Hypertension Excellence Centre; 🇪🇪 Tallin, Estonia

Hôpital européen Georges Pompidou; 🇫🇷 Paris, France

University of Oslo, Ullevaal Hospital; 🇳🇴 Oslo, Norway