Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN (ESTIM-rHTN)

August 29, 2022 updated by: Pr Patrick ROSSIGNOL

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux
      • Dinard, France
        • Hopital Arthur Gardiner
      • Grenoble, France
        • CHU de GRENOBLE
      • Lille, France
        • CHRU de Lille
      • Lyon, France
        • Hospices Civils de Lyon
      • Marseille, France
        • APHM
      • Nancy, France
        • CHRU de Nancy
      • Paris, France
        • HEGP
      • Paris, France, 75000
        • APHP -Hotel Dieu hospital
      • Paris, France
        • GH la Pitié Salpêtrière
      • Poitiers, France
        • CHU de Poitiers
      • Rennes, France, 35033
        • CHU de Rennes
      • Toulouse, France
        • CHU de TOULOUSE
      • Toulouse, France
        • Clinique Pasteur
      • Tours, France
        • CHRU De Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Baroreceptor stimulation on top of the best medical care
Baroreceptor stimulation with Barostim Neo TM
Device: Baroreceptor stimulation with Barostim Neo TM
No Intervention: Best medical care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean SBP 24h on ABPM (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Mean nocturnal SBP on ABPM (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Mean DBP 24h on ABPM (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Mean diurnal DBP on ABPM (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Mean nocturnal DBP on ABPM (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Casual SBP (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Casual DBP (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Casual PP (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Pulse wave velocity (m/s)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Central Pulse Pressure (mmHg)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Function and Left ventricular mass on echocardiography (g/m²)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Microalbuminuria (mg/mmol creatinine)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Antihypertensive regimen (Number of antihypertensive drugs)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
EuroQol5D (score)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Cardiovascular events (number of events)
Time Frame: baseline, 6 and 12 months
Comparison with usual care
baseline, 6 and 12 months
Global cardiovascular risk (scale)
Time Frame: 6 and 12 months
Comparison with usual care
6 and 12 months
Surgery Morbidity
Time Frame: 1 month
Clavien Dindo Scale, morbidity 1 month after surgery
1 month
cerebrovascular events (number of events)
Time Frame: baseline, 6 and 12 months
Comparison with usual care
baseline, 6 and 12 months
kidney events (number of events)
Time Frame: baseline, 6 and 12 months
Comparison with usual care
baseline, 6 and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost of unilateral carotid barostimulation including hospital stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
participants will be followed for the duration of hospital stay, an expected average of 2 days
ICER: difference in cost / difference in office systolic blood pressure (SBP) in mmHg
Time Frame: 12 months
12 months
ICER/ICER: difference in cost / difference in QALY (quality-of-life-adjusted survival based on the clinical trial data and the modeling results) for the lifetime modeling
Time Frame: 12 months
12 months
Budget impact (cost in Euros)
Time Frame: 4 years
4 years
Number of outpatient visits for hypertension management in both groups
Time Frame: 12 months
12 months
Morbidity
Time Frame: 6 and 12 months
Tolerance
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pr Patrick ROSSIGNOL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick ROSSIGNOL, Prof, CHRU Nancy
  • Principal Investigator: Michel AZIZI, Prof, Aphp-Hegp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-A00632-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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