BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem (BEAUTY)
This study is currently recruiting participants.
Verified November 2011 by Hemo Sapiens, Inc.
Sponsor:
Hemo Sapiens, Inc.
Information provided by (Responsible Party):
Hemo Sapiens, Inc.
ClinicalTrials.gov Identifier:
NCT01482364
First received: November 28, 2011
Last updated: December 2, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Device: Integrated hemodynamic management (IHM) - HOTMAN System Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hemo Sapiens, Inc.:
Primary Outcome Measures:
- Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up. [ Time Frame: baseline and after 6 months of treatment ] [ Designated as safety issue: No ]Absolute change in daytime SBP, under ambulatory conditions (ABPM) after 6 months follow-up.
Secondary Outcome Measures:
- The percentage of normalization of SBP (<135 mmHg) at ABPM [ Time Frame: baseline and after 6 months of treatment ] [ Designated as safety issue: No ]The percentage of normalization of SBP (<135 mmHg) at ABPM
- The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM [ Time Frame: baseline and after 6 months of treatment ] [ Designated as safety issue: No ]The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM
- Rate of side effects [ Time Frame: from baseline to 6 months of treatment ] [ Designated as safety issue: Yes ]Rate of side effects
- The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP [ Time Frame: baseline and after 6 months of treatment ] [ Designated as safety issue: No ]The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP
| Estimated Enrollment: | 250 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HOTMAN-driven therapeutic approach arm
"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
Therapeutic approach according to HOTMAN System measurement(ICG)results .
|
|
Placebo Comparator: Control arm
Control arm will receive usual antihypertensive care according to the 2007 ESH Guidelines.
|
Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System
Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482364
Contacts
| Contact: Tamara Movileanu, M.D. | + 40 729 04 69 29 | tamara.movileanu@hemosapiens.net |
| Contact: Ilie Lazarescu, M.D. | + 40 21 334 93 57 | ilie.lazarescu@hemosapiens.net |
Locations
| Estonia | |
| Tallinn Hypertension Excellence Centre | Recruiting |
| Tallin, Estonia | |
| Contact: Margus Viigima margus.viigimaa@regionaalhaigla.ee | |
| Principal Investigator: Margus Viigimaa | |
| France | |
| Hôpital européen Georges Pompidou | Not yet recruiting |
| Paris, France | |
| Contact: Stéphane Laurent stephane.laurent@egp.ap-hop-paris.fr | |
| Principal Investigator: Stephane Laurent | |
| Italy | |
| Milano Hypertension Excellence Center | Recruiting |
| Milano, Italy | |
| Contact: Gianfranco Parati gianfranco.parati@unimib.it | |
| Principal Investigator: Gianfranco Parati | |
| Norway | |
| University of Oslo, Ullevaal Hospital | Recruiting |
| Oslo, Norway | |
| Contact: Sverre Kjeldsen | |
| Principal Investigator: Sverre Kjeldsen | |
| Poland | |
| Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk | Not yet recruiting |
| Gdansk, Poland | |
| Contact: Krzysztof Narkiewicz knark@amg.gda.pl | |
| Principal Investigator: Krzysztof Narkiewicz | |
Sponsors and Collaborators
Hemo Sapiens, Inc.
Investigators
| Principal Investigator: | Stephane Laurent | Hopital europeen Georges Pompidou |
More Information
No publications provided
| Responsible Party: | Hemo Sapiens, Inc. |
| ClinicalTrials.gov Identifier: | NCT01482364 History of Changes |
| Other Study ID Numbers: | HS-01-2011 |
| Study First Received: | November 28, 2011 |
| Last Updated: | December 2, 2011 |
| Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences Poland: Ethics Committee Norway:National Committee for Medical and Health Research Ethics Estonia: Research Ethics Committee Italy: The Italian National Bioethics Committee |
Keywords provided by Hemo Sapiens, Inc.:
|
HOTMAN System Hemodynamic integrated management |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013