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

Hypertension Clinical Trial

— BEAUTY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482364
• Other study ID #: HS-01-2011
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2011
• Last updated: March 23, 2015
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: November 2011
• Source: Hemo Sapiens, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesPoland: Ethics CommitteeNorway:National Committee for Medical and Health Research EthicsEstonia: Research Ethics CommitteeItaly: The Italian National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: January 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Integrated hemodynamic management (IHM) - HOTMAN System
Therapeutic approach according to HOTMAN System measurement(ICG)results .
• Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System
Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.

Locations

Country	Name	City	State
Estonia	Tallinn Hypertension Excellence Centre	Tallin
France	Hôpital européen Georges Pompidou	Paris
Italy	Milano Hypertension Excellence Center	Milano
Norway	University of Oslo, Ullevaal Hospital	Oslo
Poland	Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Hemo Sapiens, Inc.

Countries where clinical trial is conducted

Estonia,  France,  Italy,  Norway,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	baseline and after 6 months of treatment	No
Secondary	Rate of side effects	Rate of side effects	from baseline to 6 months of treatment	Yes
Secondary	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	No