HypertensionPhase 3BEAUTYNCT01482364
BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem
A Phase 3 study testing Integrated hemodynamic management (IHM) - HOTMAN System and Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System in people with Hypertension, run by Hemo Sapiens, Inc. at 5 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Integrated hemodynamic management (IHM) - HOTMAN System and Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Oct 2011to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Poland1 site
Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk
Gdansk
About this study
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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Integrated hemodynamic management (IHM) - HOTMAN System, Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System
- Keywords
- HOTMAN System, Hemodynamic integrated management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated hemodynamic management (IHM) - HOTMAN SystemDevice
Therapeutic approach according to HOTMAN System measurement(ICG)results .
Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN SystemDevice
Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.
| Study group | Role | What they receive |
|---|---|---|
| HOTMAN-driven therapeutic approach arm | Experimental | "Hotman-driven" therapeutic approach arm(group IHM) will receive treatment according to the results of the HOTMAN® System. Receives: Device: Integrated hemodynamic management (IHM) - HOTMAN System |
| Control arm | Placebo comparator | Control arm will receive usual antihypertensive care according to the 2007 ESH Guidelines. Receives: Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and after 6 months of treatment
Secondary outcomes (4)
The percentage of normalization of SBP (<135 mmHg) at ABPM
The percentage of normalization of SBP (<135 mmHg) at ABPM
Measured: baseline and after 6 months of treatment
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
Measured: baseline and after 6 months of treatment
Rate of side effects
Rate of side effects
Measured: from baseline to 6 months of treatment
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
Measured: baseline and after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemo Sapiens, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephane Laurent, Principal investigator, Hopital europeen Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482364
- Sponsor's protocol ID
- HS-01-2011
- Acronym
- BEAUTY
- Status last verified
- Nov 2011
- First submitted
- 28 Nov 2011
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26485460
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01482364
- Acronym / sponsor ID
- BEAUTY / HS-01-2011
- Conditions
- Hypertension
- Keywords
- HOTMAN System, Hemodynamic integrated management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Hemo Sapiens, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOTMAN-driven therapeutic approach arm | Experimental | Device: 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 | Placebo comparator | Device: Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN SystemControl arm will receive usual antihypertensive care according to the 2007 ESH Guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated hemodynamic management (IHM) - HOTMAN SystemTherapeutic approach according to HOTMAN System measurement(ICG)results . | Device | HOTMAN-driven therapeutic approach arm |
| Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN SystemTherapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results. | Device | Control arm |
Primary outcome
Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up.
Time frame: baseline and after 6 months of treatment
Absolute change in daytime SBP, under ambulatory conditions (ABPM) after 6 months follow-up.
4 secondary outcomes
The percentage of normalization of SBP (<135 mmHg) at ABPM
Time frame: baseline and after 6 months of treatment
The absolute change from baseline in 24h SBP-ABPM, in 24h DBP-ABPM
Time frame: baseline and after 6 months of treatment
Rate of side effects
Time frame: from baseline to 6 months of treatment
The normalization of hemodynamics (CI, HR and SSVRI), the normalization of PWV and central BP
Time frame: baseline and after 6 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Derived from this study: PubMed 26485460Fadl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane Laurent principal investigator
Hopital europeen Georges Pompidou
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Integrated hemodynamic management (IHM) - HOTMAN System and Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System in people with Hypertension, run by Hemo Sapiens, Inc. at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Estonia, France, Italy, Norway, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in daytime SBP, under ambulatory conditions (ABPM) after a 6 months follow-up. (time frame: baseline and after 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01482364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.