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

Hemo Sapiens, Inc.

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System

Device: Integrated hemodynamic management (IHM) - HOTMAN System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01482364

HS-01-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

183 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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