HypertensionESTIM-rHTNNCT02364310
Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN
A study testing Baroreceptor stimulation with Barostim Neo TM in people with Hypertension, run by Pr Patrick ROSSIGNOL at 15 sites in France.
Trial summary
Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation with Barostim NeoTM compared to usual care in patients with resistant hypertension (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long modeling. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Baroreceptor stimulation with Barostim Neo TM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 15 sitesFrance
- Study dates
- 31 Mar 2015to 22 Jun 2021
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion Criteria:
- 18-85 years old men or women
- Resistant hypertension on 4 medications incl. thiazide or thiazide-like diuretics at appropriate doses + spironolactone (unless spironolactone intolerance)
- Essential hypertension documented (bilan < 2 years old)
- eGFR ≥ 30 ml/min/1,73 m2
- No carotid condition associated with a contra-indication for Barostim NeoTM use
Main exclusion Criteria:
- Patients with documented secondary hypertension, besides Obstructive Sleep Apnea
- Symptomatic orthostatic hypotension
- Patient with prior syncope or myocardial infarction, unstable angina pectoris, or cerebrovascular within 3 months before inclusion
- Patient with type 1 diabetes mellitus
- Patient with permanent atrial fibrillation
- Patient with brachial circumference of ≥ 46cm
- Patient with BMI>45kg/m2
- Pregnancy, breastfeeding or planning a pregnancy within 2 years
- NeoTM implantation anatomic contra-indications
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU de Bordeaux
Bordeaux
Hôpital Arthur Gardiner
Dinard
CHU de Grenoble
Grenoble
CHRU de Lille
Lille
Hospices civils de Lyon
Lyon
APHM
Marseille
CHRU de Nancy
Nancy
APHP -Hotel Dieu hospital
Paris, 75000
GH la Pitié Salpêtrière
Paris
HEGP
Paris
CHU de Poitiers
Poitiers
CHU de RENNES
Rennes, 35033
CHU de Toulouse
Toulouse
Clinique Pasteur
Toulouse
CHRU de Tours
Tours
About this study
Official title: Evaluation médico-économique de la Stimulation unilatérale du Sinus Carotidien Dans le Traitement de l'Hypertension artérielle résistante: Essai Multicentrique contrôlé, randomisé, Ouvert Avec évaluation d'efficacité Tensionnelle et de sécurité
Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation with Barostim NeoTM compared to usual care in patients with resistant hypertension (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long modeling.
- Conditions
- Hypertension
- Being tested
- Baroreceptor stimulation with Barostim Neo TM
- Keywords
- Hypertension, baroreceptor stimulation, Hypertension resistant
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baroreceptor stimulation with Barostim Neo TMDevice
| Study group | Role | What they receive |
|---|---|---|
| Baroreceptor stimulation on top of the best medical care | Experimental | Baroreceptor stimulation with Barostim Neo TM Receives: Device: Baroreceptor stimulation with Barostim Neo TM |
| Best medical care | No intervention | Best medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
12th month diurnal SBP (mmHg) measured on ABPM, adjusted on baseline SBP, also used to compute the incremental cost-effective ratio (to identify the extra cost of unilateral carotid barostimulation in BP reduction compared to usual care)
Measured: 12 months
Secondary outcomes (20)
Mean SBP 24h on ABPM (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Mean nocturnal SBP on ABPM (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Mean DBP 24h on ABPM (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Mean diurnal DBP on ABPM (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Mean nocturnal DBP on ABPM (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Casual SBP (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Casual DBP (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Casual PP (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Pulse wave velocity (m/s)
Comparison with usual care
Measured: 6 and 12 months
Central Pulse Pressure (mmHg)
Comparison with usual care
Measured: 6 and 12 months
Function and Left ventricular mass on echocardiography (g/m²)
Comparison with usual care
Measured: 6 and 12 months
Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²)
Comparison with usual care
Measured: 6 and 12 months
Microalbuminuria (mg/mmol creatinine)
Comparison with usual care
Measured: 6 and 12 months
Antihypertensive regimen (Number of antihypertensive drugs)
Comparison with usual care
Measured: 6 and 12 months
EuroQol5D (score)
Comparison with usual care
Measured: 6 and 12 months
Cardiovascular events (number of events)
Comparison with usual care
Measured: baseline, 6 and 12 months
Global cardiovascular risk (scale)
Comparison with usual care
Measured: 6 and 12 months
Surgery Morbidity
Clavien Dindo Scale, morbidity 1 month after surgery
Measured: 1 month
cerebrovascular events (number of events)
Comparison with usual care
Measured: baseline, 6 and 12 months
kidney events (number of events)
Comparison with usual care
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study start31 Mar 2015
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr Patrick ROSSIGNOL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr Patrick ROSSIGNOL, Central Hospital, Nancy, France
- Investigators
- Patrick ROSSIGNOL, Prof, Principal investigator, CHRU NancyMichel AZIZI, Prof, Principal investigator, APHP-HEGP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364310
- Sponsor's protocol ID
- 2014-A00632-45
- Acronym
- ESTIM-rHTN
- Status last verified
- Aug 2022
- First submitted
- 2 Feb 2015
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation médico-économique de la Stimulation unilatérale du Sinus Carotidien Dans le Traitement de l'Hypertension artérielle résistante: Essai Multicentrique contrôlé, randomisé, Ouvert Avec évaluation d'efficacité Tensionnelle et de sécurité
- ClinicalTrials.gov ID
- NCT02364310
- Acronym / sponsor ID
- ESTIM-rHTN / 2014-A00632-45
- Conditions
- Hypertension
- Keywords
- Hypertension, baroreceptor stimulation, Hypertension resistant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Pr Patrick ROSSIGNOLUniversity, hospital or other
- Study start
- 31 Mar 2015 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 18 Feb 2015 (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.
Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation with Barostim NeoTM compared to usual care in patients with resistant hypertension (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long modeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baroreceptor stimulation on top of the best medical care | Experimental | Device: Baroreceptor stimulation with Barostim Neo TMBaroreceptor stimulation with Barostim Neo TM |
| Best medical care | No intervention | –Best medical care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Baroreceptor stimulation with Barostim Neo TM | Device | Baroreceptor stimulation on top of the best medical care |
Primary outcome
12th month diurnal SBP (mmHg) measured on ABPM, adjusted on baseline SBP, also used to compute the incremental cost-effective ratio (to identify the extra cost of unilateral carotid barostimulation in BP reduction compared to usual care)
Time frame: 12 months
20 secondary outcomes
Mean SBP 24h on ABPM (mmHg)
Time frame: 6 and 12 months
Mean nocturnal SBP on ABPM (mmHg)
Time frame: 6 and 12 months
Mean DBP 24h on ABPM (mmHg)
Time frame: 6 and 12 months
Mean diurnal DBP on ABPM (mmHg)
Time frame: 6 and 12 months
Mean nocturnal DBP on ABPM (mmHg)
Time frame: 6 and 12 months
Casual SBP (mmHg)
Time frame: 6 and 12 months
Casual DBP (mmHg)
Time frame: 6 and 12 months
Casual PP (mmHg)
Time frame: 6 and 12 months
Pulse wave velocity (m/s)
Time frame: 6 and 12 months
Central Pulse Pressure (mmHg)
Time frame: 6 and 12 months
Function and Left ventricular mass on echocardiography (g/m²)
Time frame: 6 and 12 months
Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²)
Time frame: 6 and 12 months
Microalbuminuria (mg/mmol creatinine)
Time frame: 6 and 12 months
Antihypertensive regimen (Number of antihypertensive drugs)
Time frame: 6 and 12 months
EuroQol5D (score)
Time frame: 6 and 12 months
Cardiovascular events (number of events)
Time frame: baseline, 6 and 12 months
Global cardiovascular risk (scale)
Time frame: 6 and 12 months
Surgery Morbidity
Time frame: 1 month
cerebrovascular events (number of events)
Time frame: baseline, 6 and 12 months
kidney events (number of events)
Time frame: baseline, 6 and 12 months
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 1 Sep 2022.
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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.
Patrick ROSSIGNOL, Prof principal investigator
CHRU Nancy
Michel AZIZI, Prof principal investigator
APHP-HEGP
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baroreceptor stimulation with Barostim Neo TM in people with Hypertension, run by Pr Patrick ROSSIGNOL at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
12th month diurnal SBP (mmHg) measured on ABPM, adjusted on baseline SBP, also used to compute the incremental cost-effective ratio (to identify the extra cost of unilateral carotid barostimulation in BP reduction compared to usual care) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2022.