NCT02364310

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2015

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2021

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

6.2 years

First QC Date

February 2, 2015

Last Update Submit

August 29, 2022

Conditions

Hypertension

Keywords

Hypertensionbaroreceptor stimulationHypertension resistant

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months

Secondary Outcomes (20)

  • Mean SBP 24h on ABPM (mmHg)

    6 and 12 months

  • Mean nocturnal SBP on ABPM (mmHg)

    6 and 12 months

  • Mean DBP 24h on ABPM (mmHg)

    6 and 12 months

  • Mean diurnal DBP on ABPM (mmHg)

    6 and 12 months

  • Mean nocturnal DBP on ABPM (mmHg)

    6 and 12 months

  • +15 more secondary outcomes

Other Outcomes (6)

  • Cost of unilateral carotid barostimulation including hospital stay

    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

    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

    12 months

  • +3 more other outcomes

Study Arms (2)

Baroreceptor stimulation on top of the best medical care

EXPERIMENTAL

Baroreceptor stimulation with Barostim Neo TM

Device: Baroreceptor stimulation with Barostim Neo TM

Best medical care

NO INTERVENTION

Best medical care

Interventions

Baroreceptor stimulation with Barostim Neo TMDEVICE
Baroreceptor stimulation on top of the best medical care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with documented secondary hypertension, besides Obstructive Sleep Apnea
  • Symptomatic orthostatic hypotension
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU de Bordeaux

Bordeaux, France

Location

Hôpital Arthur Gardiner

Dinard, France

Location

CHU de Grenoble

Grenoble, France

Location

CHRU de Lille

Lille, France

Location

Hospices civils de Lyon

Lyon, France

Location

APHM

Marseille, France

Location

CHRU de Nancy

Nancy, France

Location

APHP -Hotel Dieu hospital

Paris, 75000, France

Location

GH la Pitié Salpêtrière

Paris, France

Location

HEGP

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de RENNES

Rennes, 35033, France

Location

CHU de Toulouse

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

CHRU de Tours

Tours, France

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Patrick ROSSIGNOL, Prof

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

  • Michel AZIZI, Prof

    APHP-HEGP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PU-PH

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 18, 2015

Study Start

March 31, 2015

Primary Completion

June 22, 2021

Study Completion

June 22, 2021

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations

FR(15)