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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

Pr Patrick ROSSIGNOL

Investigators

  • 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)

March 31, 2015

Primary Completion (Actual)

June 22, 2021

Study Completion (Actual)

June 22, 2021

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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