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THRIVE - Système de dénervation rénale par échographie intravasculaire thérapeutique (TIVUS ™) par rapport à une simulation pour le traitement d'appoint de l'hypertension (THRIVE)

21 septembre 2026 mis à jour par: SoniVie Inc.

Une étude pivot, prospective, multicentrique, randomisée 2: 1, en double aveugle, contrôlée, comparant le système de dénervation rénale thérapeutique par ultrasons intravasculaires (TIVUS ™) à un traitement fictif pour le traitement d'appoint de l'hypertension (l'étude THRIVE)

The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in:

  1. subjects with uncontrolled hypertension (HTN) receiving 0 - 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure.
  2. subjects with controlled hypertension receiving 1 - 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

THRIVE is an international, multicenter, randomized, double blind, sham-controlled study, designed to demonstrate the adjunctive effectiveness and safety of the TIVUS System in hypertensive subjects while subjects are maintained off-antihypertensive medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after procedure. At two months after procedure, subjects with uncontrolled hypertension are put back on antihypertensive medication according to a medication escalation protocol. Unblinding will be performed at 6 months. Uncontrolled sham subjects can cross-over to RDN procedure at 6-months. The sham procedure will be minimally invasive to reduce risk to subjects. All subjects treated with TIVUS will be followed for a maximum of 36 months post procedure.

Type d'étude

Interventionnel

Inscription (Estimé)

261

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Allemagne
      • Dresden, Allemagne
        • Recrutement
        • Dresden TUD University of Technology
        • Contact:
          • Axel Linke, MD, PhD
      • Erlangen, Allemagne
        • Recrutement
        • Universitätsklinikum Erlangen
        • Contact:
          • Roland Schmieder, MD, PhD
      • Frankfurt, Allemagne
        • Recrutement
        • Frankfurt Sankt Katharinen Krankenhaus
        • Contact:
          • Horst Sievert, MD
      • Freiburg im Breisgau, Allemagne
        • Recrutement
        • Freiburg Herzzenrtum
        • Contact:
          • Elias Noory, MD
      • Hamburg, Allemagne
        • Recrutement
        • Marienkrankenhaus Hamburg
        • Contact:
          • Jury Schewel, MD
      • Herne, Allemagne
        • Recrutement
        • Herne Marien Hospital
        • Contact:
          • Christian Ukena, MD, PhD
      • Homburg, Allemagne
        • Recrutement
        • Saarland University Hospital
        • Contact:
          • Kulenthiran Saarraaken, MD
      • Leipzig, Allemagne
        • Recrutement
        • Herzzentrum Leipzig
        • Contact:
          • Karl Fengler, MD
      • Lübeck, Allemagne
        • Recrutement
        • Sana Kliniken Lubeck
        • Contact:
          • Joachim Weil, MD
  • France
      • Bordeaux, France
        • Recrutement
        • Hopital Saint André
        • Contact:
          • Antoine Cremer, MD
      • Paris, France
        • Recrutement
        • Hôpital Européen Georges-Pompidou
        • Contact:
          • Michel Azizi, MD, PhD
  • Grèce
      • Athens, Grèce
        • Recrutement
        • Athens Hippokration
        • Contact:
          • K Tsioufis, MD, PhD
      • Heraklion, Grèce
        • Recrutement
        • University of Crete
        • Contact:
          • Maria Marketou, MD, PhD
      • Thessaloniki, Grèce
        • Recrutement
        • Thessaloniki Hippokration General Hospital
        • Contact:
          • Michalis Doumas, MD
  • Italie
      • Mercogliano, Italie
        • Recrutement
        • Clinica Montevergine
        • Contact:
          • Luigi Salemme, MD
      • Monza, Italie
        • Recrutement
        • Monza Policlinico
        • Contact:
          • Filippo Scalise, MD
      • Roma, Italie
        • Recrutement
        • Ospedale Sant'Andrea
        • Contact:
          • Emanuele Barbato, MD, PhD
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35211
        • Recrutement
        • Cardiology, PC
        • Contact:
        • Chercheur principal:
          • Farrell O Mendelsohn
    • Arizona
      • Scottsdale, Arizona, États-Unis, 85258
    • Arkansas
    • California
      • Los Angeles, California, États-Unis, 90048
      • Palo Alto, California, États-Unis, 94305
        • Recrutement
        • Stanford University
        • Contact:
          • David Lee, MD
    • Connecticut
      • Bridgeport, Connecticut, États-Unis, 06610
        • Recrutement
        • Connecticut Clinical Research, LLC (Bridgeport)
        • Contact:
          • Edward Tuohy, MD
    • Florida
      • Pensacola, Florida, États-Unis, 32504
      • Safety Harbor, Florida, États-Unis, 34695
        • Recrutement
        • Baycare Health System
        • Contact:
          • Parag Patel, MD
      • Tampa, Florida, États-Unis, 33606
        • Recrutement
        • University of South Florida
        • Contact:
          • Fadi Matar, MD
    • Illinois
      • Elk Grove Village, Illinois, États-Unis, 60007
        • Recrutement
        • Ascension Alexian Brothers
        • Chercheur principal:
          • Alexander Fraley, M.D.
      • Springfield, Illinois, États-Unis, 62794
        • Recrutement
        • Southern Illinois University, School of Medicine
        • Contact:
      • Springfield, Illinois, États-Unis, 62710
        • Recrutement
        • St. John's Prairie Heart
        • Contact:
          • Avinash Murthy, MD
    • Louisiana
      • Houma, Louisiana, États-Unis, 70360
      • New Orleans, Louisiana, États-Unis, 70121
        • Recrutement
        • Ochsner Medical Center
        • Contact:
          • James Jenkins, MD
    • Michigan
    • Mississippi
      • Gulfport, Mississippi, États-Unis, 39501
        • Recrutement
        • Gulfport Memorial Hospital
        • Contact:
          • Wayne Latack, MD
      • Jackson, Mississippi, États-Unis, 39216
        • Recrutement
        • Jackson Heart Clinic
        • Contact:
          • J. Gray Bennett, MD
    • Missouri
      • Kansas City, Missouri, États-Unis, 64131
    • Nevada
      • Reno, Nevada, États-Unis, 89502
    • New Jersey
      • Camden, New Jersey, États-Unis, 08103
        • Recrutement
        • Virtua Health
        • Contact:
          • Kintur Sanghvi, MD
      • Neptune City, New Jersey, États-Unis, 07753
    • New York
      • Liverpool, New York, États-Unis, 13088
        • Recrutement
        • St. Joseph
        • Contact:
          • Ayman Iskander, MD
      • New York, New York, États-Unis, 10032
        • Recrutement
        • Nyph/Cumc
        • Contact:
          • Ari Mintz, MD
    • North Carolina
    • Oklahoma
      • Bartlesville, Oklahoma, États-Unis, 74006
        • Recrutement
        • Ascension St. John Clinical Research Institute
        • Contact:
          • Anderson Mehrle, MD
    • Pennsylvania
      • Lancaster, Pennsylvania, États-Unis, 17603
        • Recrutement
        • Lancaster General Health
        • Contact:
          • Rupal Dumasia, MD
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Recrutement
        • Penn Medicine
        • Contact:
          • Deborah Cohen, MD
    • South Carolina
      • Mt. Pleasant, South Carolina, États-Unis, 29464
        • Recrutement
        • MUSC
        • Contact:
          • Thomas Todoran, MD, MS
    • Texas
      • Fort Worth, Texas, États-Unis, 76104
        • Recrutement
        • Plaza Medical Center of Fort Worth
        • Contact:
          • Farhan Ali, M.D.
      • Houston, Texas, États-Unis, 77004
    • Utah
    • Virginia
      • Richmond, Virginia, États-Unis, 23225

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

22 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Appropriately signed and dated informed consent

  2. Male and female adults with age between ≥22 and ≤75 years at time of consent

  3. Documented history of hypertension

  4. Previously or currently prescribed antihypertensive therapy

  5. Subject has an office BP (average of 3 seated measurements) of:

    1. Uncontrolled BP: ≥ 140/90 mmHg <180/110 mmHg at Screening Visit (V0) while stable for at least 4 weeks on 0-2 anti-hypertensive medications of different classes* and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure, (subjects with a history of treatment with anti-hypertensive medications but are not currently taking any at screening will undergo a 4-week run-in period) or,
    2. Controlled BP: < 140/90 mmHg while stable for at least 4 weeks on 1-2 antihypertensive medications of different classes and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure

  6. Able and willing to comply with all study procedures

  7. Subject is willing to have and is a good candidate for conscious sedation

Subjects who meet the following criteria will be considered eligible for randomization:

  • Documented daytime systolic ABP ≥ 135 mmHg and < 180 mmHg after 4-week washout/run-in period.**

  • Suitable renal anatomy compatible with the renal denervation procedure, documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in subjects without a recent (≤1 year) cross-sectional renal imaging). The renal angiogram procedure done in the cath lab prior to randomization will serve as the final anatomy compatibility check.

    • Potassium-sparing diuretics such as Amiloride hydrochloride and Triamterene may be prescribed in combination with another diuretic (e.g. a thiazide or loop diuretic) for their potassium conservation properties. In this situation, the diuretic combination is considered as a single class of anti-hypertensive.

Exclusion Criteria:

  1. Subject has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as a single kidney, ectopic or horseshoe kidney, polycystic kidney disease, kidney tumors or other findings precluding renal denervation therapy as detailed in the angiographic exclusion criteria

  2. Uncorrected causes of secondary hypertension other than sleep apnea (including, but not limited to): aldosteronism, renal parenchymal disease, renovascular disease, excess catecholamines, Cushing's syndrome, erythropoietin use, pheochromocytoma, hypo/hyperthyroidism, hyperparathyroidism, acromegaly)

  3. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥ 9.0%)

  4. eGFR of <40 mL/min/1.73 m2 CKD-EPI as calculated using the CKD-EPI 2021 equation

  5. Cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 6 months prior to consent

  6. History of severe cardiovascular event (e.g. myocardial infarction, unstable angina, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 12 months prior to consent

  7. Subject has severe valvular stenosis or insufficiency

  8. Documented repeat (>1) hospitalization for hypertensive crisis within the prior 12 months and/or any hospitalization for hypertensive crisis within three (3) months prior to consent

  9. Prescribed to any standard antihypertensive cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health in the opinion of the investigator

  10. Subject with rapid, uncontrolled, symptomatic atrial fibrillation

  11. Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)

  12. Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.

  13. Subject has a planned major surgery (any procedure requiring general anesthesia) in the next 12 months.

  14. Subject on anticoagulant therapy that cannot be temporarily withheld for study procedure.

  15. Primary pulmonary hypertension

  16. Documented contraindication or allergy to contrast medium not amenable to treatment

  17. Limited life expectancy of < 1 year at the discretion of the Investigator

  18. Night shift worker

  19. Subject has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.

  20. Subject is taking immunosuppressive therapy for diseases featuring vasculitis

  21. Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders

  22. Pregnant, nursing or planning to become pregnant within 12 months post procedure.

    Negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of childbearing potential. Documentation of effective contraception is also required for women of childbearing potential

  23. Subject has a planned major surgery or cardiovascular intervention in the next 6 months

  24. Subject with history of renal transplantation

  25. Evidence of active infection within 7 days of procedure (based on positive lab test and requiring therapy).

  26. Subject has hypertrophic cardiomyopathy or amyloidosis.

  27. Prior renal denervation procedure

  28. Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional studies/registries is acceptable)

  29. Subject on a beta blocker for a condition other than antihypertension

Angiographic Exclusion Criteria:

The following characteristics identified either on the renal artery CT scan or MRI or on the Eligibility II Renal artery Angiogram will prevent the subject from being included:

  1. Main renal arteries lumen diameter < 4 mm.
  2. Main renal treatable artery length <20mm (may include proximal branching).
  3. Accessory renal arteries that supplies ≥ 25% of the parenchyma, and < 4 mm in lumen diameter.
  4. Aorto-renal angle that prevents a safe cannulation of the renal artery.
  5. Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the TIVUS™ procedure.
  6. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation (NOTE: vessel areas with calcification and fibromuscular dysplasia (FMD) should be avoided as intended treatment areas).
  7. Any renal artery stenosis > 30% by visual assessment.
  8. Any renal artery aneurysm (>50% of the main renal artery reference vessel diameter by visual estimate).
  9. Presence of fibromuscular dysplasia of the renal arteries
  10. Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: TIVUS™ Renal Denervation System

Following angiogram, subjects found anatomically eligible and randomized to the renal denervation arm will be treated with the TIVUS™ Renal Denervation System.
Dispositif: TIVUS™ Renal Denervation System

Renal artery catheterization procedure used to denervate the renal sympathetic nerves in the perivascular space using ultrasound energy.

Autres noms:
  • Dénervation rénale
Comparateur factice: Sham

For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Autre: Sham

For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Reduction in average daytime ambulatory systolic BP
Délai: From baseline to 2 months post-procedure

Primary outcome
From baseline to 2 months post-procedure
Subject level composite of the incidence of Major Adverse Events (MAE)
Délai: From Baseline to 30 day and 6 months post procedure

Safety outcome
From Baseline to 30 day and 6 months post procedure

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Reduction in average 24-hr ambulatory systolic BP
Délai: From baseline to 2 Months post procedure

Secondary outcome
From baseline to 2 Months post procedure
Reduction in average home systolic BP
Délai: From baseline to 2 Months post procedure

Secondary outcome
From baseline to 2 Months post procedure
Reduction in average office systolic BP
Délai: From baseline to 2 Months post procedure

Secondary outcome
From baseline to 2 Months post procedure
Reduction in average daytime ambulatory diastolic BP
Délai: From baseline to 2 Months post procedure

Secondary outcome
From baseline to 2 Months post procedure
Reduction in average 24-hr ambulatory diastolic BP
Délai: From baseline to 2 Months post procedure

Secondary outcome
From baseline to 2 Months post procedure
Reduction in average home diastolic BP
Délai: From baseline to 2 Months post procedure

Secondary outcome
From baseline to 2 Months post procedure
Reduction in average office diastolic BP
Délai: From baseline to 2 Months post procedure

Secondary outcome
From baseline to 2 Months post procedure
Percentage of subjects with Systolic Blood Pressure (SBP) at target (daytime SBP <135 mmHg; office SBP <140
Délai: From baseline to 2 and 6 Months post procedure

Secondary outcome
From baseline to 2 and 6 Months post procedure
Percentage of subjects with SBP at target (daytime SBP <135 mmHg; office SBP <140 mmHg) in the absence of. changes in hypertensive medication in each arm
Délai: From baseline to 2 and 6 Months post procedure

Secondary outcome
From baseline to 2 and 6 Months post procedure
Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mm Hg
Délai: From baseline to 2, 6, and 12 Months post procedure

Secondary outcome
From baseline to 2, 6, and 12 Months post procedure

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Reduction in average night-time ambulatory systolic/diastolic BP
Délai: From baseline to 2, 6 and 12, Months post procedure

Observational outcome
From baseline to 2, 6 and 12, Months post procedure
Reduction in average daytime & 24-hr ambulatory systolic BP at 6- and 12-months post procedure.
Délai: From baseline to 6 and 12 Months post procedure

Observational outcome
From baseline to 6 and 12 Months post procedure
Reduction in average daytime & 24-hr ambulatory diastolic BP
Délai: From baseline to 6 and 12 Months post procedure

Observational outcome
From baseline to 6 and 12 Months post procedure
Reduction in average office systolic BP
Délai: From baseline to 6 and 12 Months post procedure

Observational outcome
From baseline to 6 and 12 Months post procedure
Reduction in average home systolic/diastolic BP
Délai: From baseline to 1, 3, 4, 5, 6, and 12-Months post procedure

Observational outcome
From baseline to 1, 3, 4, 5, 6, and 12-Months post procedure
Reduction in office and ambulatory pulse pressure
Délai: From baseline to 2, 6 and 12 Months post procedure

Observational outcome
From baseline to 2, 6 and 12 Months post procedure
Reduction in office and ambulatory heart rate
Délai: From baseline to 2, 6, and 12 Months post procedure

Observational outcome
From baseline to 2, 6, and 12 Months post procedure
Antihypertensive medication burden (number of antihypertensive drugs, doses, classes)
Délai: From baseline to 2, 6 and 12 Months post procedure

Observational outcome
From baseline to 2, 6 and 12 Months post procedure
Percentage of subjects meeting escape criteria
Délai: From baseline to 2 Months post procedure

Observational outcome
From baseline to 2 Months post procedure
Percentage of subjects requiring initiation of antihypertensive drug therapy
Délai: From baseline to 2 and 6 Months post procedure

Observational outcome
From baseline to 2 and 6 Months post procedure
Percentage of subjects without any antihypertensive treatment
Délai: From baseline to 6 and 12 Months post procedure

Observational outcome
From baseline to 6 and 12 Months post procedure
Percentage of subjects requiring initiation of anti-hypertensive drug therapy at any available time points post procedure
Délai: From baseline through completion of study

Observational outcome
From baseline through completion of study
Change in adherence to medications assessed by urine chemical adherence testing using liquid chromatography with tandem mass spectrometry (LCMSMS)
Délai: From baseline to 2, 6, 12, 24 and 36 Months.

Observational outcome
From baseline to 2, 6, 12, 24 and 36 Months.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

SoniVie Inc.

Collaborateurs

European Cardiovascular Research Center
NAMSA
IQVIA Pty Ltd

Les enquêteurs

  • Chaise d'étude: Ajay Kirtane, MD, Columbia University
  • Chaise d'étude: Michel Azizi, MD, George Pompidou Hospital
  • Chaise d'étude: Felix Mahfoud, MD, University of Basel

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 octobre 2024

Achèvement primaire (Estimé)

31 mars 2027

Achèvement de l'étude (Estimé)

15 août 2028

Dates d'inscription aux études

Première soumission

24 juillet 2024

Première soumission répondant aux critères de contrôle qualité

15 août 2024

Première publication (Réel)

19 août 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CLNS07-001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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