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

NCT01482364 | Completed Phase 3

• 1 other identifier: HS-01-2011
• Study Type: interventional
• Target: 183
• Locations: 5 countries
• Sites: 5

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.

Conditions

Hypertension

Keywords

HOTMAN System; Hemodynamic integrated management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• The percentage of normalization of SBP (<135 mmHg) at ABPM

  baseline and after 6 months of treatment

• The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM

  baseline and after 6 months of treatment

• Rate of side effects

  from baseline to 6 months of treatment

• The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP

  baseline and after 6 months of treatment

Study Arms (2)

HOTMAN-driven therapeutic approach arm

EXPERIMENTAL

"Hotman-driven" therapeutic approach arm(group IHM) will receive treatment according to the results of the HOTMAN® System.

Device: Integrated hemodynamic management (IHM) - HOTMAN System

Control arm

PLACEBO COMPARATOR

Control arm will receive usual antihypertensive care according to the 2007 ESH Guidelines.

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

Interventions

Integrated hemodynamic management (IHM) - HOTMAN System DEVICE

Therapeutic approach according to HOTMAN System measurement(ICG)results .

HOTMAN-driven therapeutic approach arm

Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System DEVICE

Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.

Control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hemo Sapiens, Inc.: lead

Study Sites (5)

Tallinn Hypertension Excellence Centre

Tallinn, Estonia

Location

Hôpital européen Georges Pompidou

Paris, France

Location

Milano Hypertension Excellence Center

Milan, Italy

Location

University of Oslo, Ullevaal Hospital

Oslo, Norway

Location

Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk

Gdansk, Poland

Location

Related Publications (1)

• 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.

  PMID: 26485460 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephane Laurent

  Hopital europeen Georges Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: November 30, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2011-11

Locations

IT (1); NO (1); FR (1); PL (1); ES (1)