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

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ClinicalTrials.gov Identifier: NCT02364310
Recruitment Status : Recruiting
First Posted : February 18, 2015
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Baroreceptor stimulation with Barostim Neo TM Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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
Best medical care



Primary Outcome Measures :
  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) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean SBP 24h on ABPM (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  2. Mean nocturnal SBP on ABPM (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  3. Mean DBP 24h on ABPM (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  4. Mean diurnal DBP on ABPM (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  5. Mean nocturnal DBP on ABPM (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  6. Casual SBP (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  7. Casual DBP (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  8. Casual PP (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  9. Pulse wave velocity (m/s) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  10. Central Pulse Pressure (mmHg) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  11. Function and Left ventricular mass on echocardiography (g/m²) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  12. Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  13. Microalbuminuria (mg/mmol creatinine) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  14. Antihypertensive regimen (Number of antihypertensive drugs) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  15. EuroQol5D (score) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  16. Compliance (Morisky self-questionnaire and drug concentrations measurements) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  17. Cardiovascular events (number of events) [ Time Frame: baseline, 6 and 12 months ]
    Comparison with usual care

  18. Global cardiovascular risk (scale) [ Time Frame: 6 and 12 months ]
    Comparison with usual care

  19. Surgery Morbidity [ Time Frame: 1 month ]
    Clavien Dindo Scale, morbidity 1 month after surgery

  20. cerebrovascular events (number of events) [ Time Frame: baseline, 6 and 12 months ]
    Comparison with usual care

  21. kidney events (number of events) [ Time Frame: baseline, 6 and 12 months ]
    Comparison with usual care


Other Outcome Measures:
  1. 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 ]
  2. ICER: difference in cost / difference in office systolic blood pressure (SBP) in mmHg [ Time Frame: 12 months ]
  3. 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 ]
  4. Budget impact (cost in Euros) [ Time Frame: 4 years ]
  5. Number of outpatient visits for hypertension management in both groups [ Time Frame: 12 months ]
  6. Morbidity [ Time Frame: 6 and 12 months ]
    Tolerance



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364310


Contacts
Contact: Patrick ROSSIGNOL, Investigator coordinator +33 383157322 p.rossignol@chu-nancy.fr
Contact: Michel AZIZI, Investigator co coordinator + 33 1 56 09 29 12 / 29 45 michel.azizi@aphp.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Philippe GOSSE, Prof         
Principal Investigator: Philippe GOSSE, Prof         
Hôpital Arthur Gardiner Recruiting
Dinard, France
Contact: Thierry Denolle, Prof         
Principal Investigator: Thierry Denole, Prof         
CHU de Grenoble Recruiting
Grenoble, France
Contact: Olivier ORMEZZANO         
Principal Investigator: Olivier ORMEZZANO, Prof         
CHRU de Lille Recruiting
Lille, France
Contact: Pascal DELSART, Prof         
Principal Investigator: Pascal DELSART, Prof         
Hospices civils de Lyon Recruiting
Lyon, France
Contact: Pierre LANTELME, Prof         
Principal Investigator: Pierre LANTELME, Prof         
APHM Recruiting
Marseille, France
Contact: Bernard VAISSE, Prof         
Principal Investigator: Bernard VAISSE, Prof         
CHRU de Nancy Recruiting
Nancy, France
Contact: Patrick Rossignol, Prof         
Principal Investigator: Patrick Patrick, Prof         
APHP -Hotel Dieu hospital Recruiting
Paris, France, 75000
Contact: BLACHER Jacques, Prof         
Principal Investigator: BLACHER Jacques, Prof         
GH la Pitié Salpêtrière Recruiting
Paris, France
Contact: Xavier GIRERD, Prof         
Principal Investigator: Xavier GIRERD, Prof         
HEGP Recruiting
Paris, France
Contact: Michel AZIZI, Prof         
Principal Investigator: Michel AZIZI, Prof         
CHU de Poitiers Recruiting
Poitiers, France
Contact: Samy HADJADJ, Prof         
Principal Investigator: Samy HADJADJ, Prof         
CHU de RENNES Recruiting
Rennes, France, 35033
Contact: DOURMAP-COLLAS Caroline, MD         
Principal Investigator: DOURMAP-COLLAS Caroline         
CHU de Toulouse Recruiting
Toulouse, France
Contact: Béatrice DULY-BOUHANICK, Prof         
Principal Investigator: Béatrice DULY-BOUHANICK, Prof         
Clinique Pasteur Recruiting
Toulouse, France
Contact: Atul PATHAK, Prof         
Principal Investigator: Atul PATHAK, Prof         
CHRU de Tours Recruiting
Tours, France
Contact: Jean-Michel Halimi, Prof         
Principal Investigator: Jean-Michel Halimi, Prof         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Patrick ROSSIGNOL, Prof CHRU Nancy
Principal Investigator: Michel AZIZI, Prof APHP-HEGP

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02364310     History of Changes
Other Study ID Numbers: 2014-A00632-45
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: December 2017

Keywords provided by Central Hospital, Nancy, France:
Hypertension
baroreceptor stimulation
Hypertension resistant

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases