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Completed

NCT Number: NCT02364310

Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baroreceptor stimulation with Barostim Neo TM

Device

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)

    Time frame: 12 months

Secondary outcomes

  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. Cardiovascular events (number of events)

    Time frame: baseline, 6 and 12 months

    Comparison with usual care

  17. Global cardiovascular risk (scale)

    Time frame: 6 and 12 months

    Comparison with usual care

  18. Surgery Morbidity

    Time frame: 1 month

    Clavien Dindo Scale, morbidity 1 month after surgery

  19. cerebrovascular events (number of events)

    Time frame: baseline, 6 and 12 months

    Comparison with usual care

  20. kidney events (number of events)

    Time frame: baseline, 6 and 12 months

    Comparison with usual care

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Pr Patrick ROSSIGNOL

Other

Registry information

Official study 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

Acronym: ESTIM-rHTN

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2015
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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