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THRIVE- Terapeutisk intravaskulær ultralyd (TIVUS™) renalt denerveringssystem versus sham for tilleggsbehandling av hypertensjon (THRIVE)

21. september 2026 oppdatert av: SoniVie Inc.

En pivotal, prospektiv, multisenter, 2:1 randomisert, dobbeltblind, kontrollert, studie som sammenligner det terapeutiske intravaskulære ultralyd (TIVUS™) renalt denerveringssystem versus sham for tilleggsbehandling av hypertensjon (The THRIVE-studien)

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

261

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35211
        • Rekruttering
        • Cardiology, PC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Farrell O Mendelsohn
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85258
    • Arkansas
    • California
      • Los Angeles, California, Forente stater, 90048
      • Palo Alto, California, Forente stater, 94305
        • Rekruttering
        • Stanford University
        • Ta kontakt med:
          • David Lee, MD
    • Connecticut
      • Bridgeport, Connecticut, Forente stater, 06610
        • Rekruttering
        • Connecticut Clinical Research, LLC (Bridgeport)
        • Ta kontakt med:
          • Edward Tuohy, MD
    • Florida
      • Pensacola, Florida, Forente stater, 32504
      • Safety Harbor, Florida, Forente stater, 34695
        • Rekruttering
        • Baycare Health System
        • Ta kontakt med:
          • Parag Patel, MD
      • Tampa, Florida, Forente stater, 33606
        • Rekruttering
        • University of South Florida
        • Ta kontakt med:
          • Fadi Matar, MD
    • Illinois
      • Elk Grove Village, Illinois, Forente stater, 60007
        • Rekruttering
        • Ascension Alexian Brothers
        • Hovedetterforsker:
          • Alexander Fraley, M.D.
      • Springfield, Illinois, Forente stater, 62794
        • Rekruttering
        • Southern Illinois University, School of Medicine
        • Ta kontakt med:
      • Springfield, Illinois, Forente stater, 62710
        • Rekruttering
        • St. John's Prairie Heart
        • Ta kontakt med:
          • Avinash Murthy, MD
    • Louisiana
      • Houma, Louisiana, Forente stater, 70360
      • New Orleans, Louisiana, Forente stater, 70121
        • Rekruttering
        • Ochsner Medical Center
        • Ta kontakt med:
          • James Jenkins, MD
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
      • Southfield, Michigan, Forente stater, 48075
    • Mississippi
      • Gulfport, Mississippi, Forente stater, 39501
        • Rekruttering
        • Gulfport Memorial Hospital
        • Ta kontakt med:
          • Wayne Latack, MD
      • Jackson, Mississippi, Forente stater, 39216
        • Rekruttering
        • Jackson Heart Clinic
        • Ta kontakt med:
          • J. Gray Bennett, MD
    • Missouri
      • Kansas City, Missouri, Forente stater, 64131
    • Nevada
      • Reno, Nevada, Forente stater, 89502
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Rekruttering
        • Virtua Health
        • Ta kontakt med:
          • Kintur Sanghvi, MD
      • Neptune City, New Jersey, Forente stater, 07753
        • Rekruttering
        • Jersey Shore University Medical Center
        • Ta kontakt med:
    • New York
      • Liverpool, New York, Forente stater, 13088
        • Rekruttering
        • St. Joseph
        • Ta kontakt med:
          • Ayman Iskander, MD
      • New York, New York, Forente stater, 10032
        • Rekruttering
        • Nyph/Cumc
        • Ta kontakt med:
          • Ari Mintz, MD
    • North Carolina
    • Oklahoma
      • Bartlesville, Oklahoma, Forente stater, 74006
        • Rekruttering
        • Ascension St. John Clinical Research Institute
        • Ta kontakt med:
          • Anderson Mehrle, MD
    • Pennsylvania
      • Lancaster, Pennsylvania, Forente stater, 17603
        • Rekruttering
        • Lancaster General Health
        • Ta kontakt med:
          • Rupal Dumasia, MD
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Rekruttering
        • Penn Medicine
        • Ta kontakt med:
          • Deborah Cohen, MD
    • South Carolina
      • Mt. Pleasant, South Carolina, Forente stater, 29464
        • Rekruttering
        • MUSC
        • Ta kontakt med:
          • Thomas Todoran, MD, MS
    • Texas
      • Fort Worth, Texas, Forente stater, 76104
        • Rekruttering
        • Plaza Medical Center of Fort Worth
        • Ta kontakt med:
          • Farhan Ali, M.D.
      • Houston, Texas, Forente stater, 77004
    • Utah
    • Virginia
      • Richmond, Virginia, Forente stater, 23225
  • Frankrike
      • Bordeaux, Frankrike
        • Rekruttering
        • Hopital Saint André
        • Ta kontakt med:
          • Antoine Cremer, MD
      • Paris, Frankrike
        • Rekruttering
        • Hôpital Européen Georges-Pompidou
        • Ta kontakt med:
          • Michel Azizi, MD, PhD
  • Hellas
      • Athens, Hellas
        • Rekruttering
        • Athens Hippokration
        • Ta kontakt med:
          • K Tsioufis, MD, PhD
      • Heraklion, Hellas
        • Rekruttering
        • University of Crete
        • Ta kontakt med:
          • Maria Marketou, MD, PhD
      • Thessaloniki, Hellas
        • Rekruttering
        • Thessaloniki Hippokration General Hospital
        • Ta kontakt med:
          • Michalis Doumas, MD
  • Italia
      • Mercogliano, Italia
        • Rekruttering
        • Clinica Montevergine
        • Ta kontakt med:
          • Luigi Salemme, MD
      • Monza, Italia
        • Rekruttering
        • Monza Policlinico
        • Ta kontakt med:
          • Filippo Scalise, MD
      • Roma, Italia
        • Rekruttering
        • Ospedale Sant'Andrea
        • Ta kontakt med:
          • Emanuele Barbato, MD, PhD
  • Tyskland
      • Dresden, Tyskland
        • Rekruttering
        • Dresden TUD University of Technology
        • Ta kontakt med:
          • Axel Linke, MD, PhD
      • Erlangen, Tyskland
        • Rekruttering
        • Universitätsklinikum Erlangen
        • Ta kontakt med:
          • Roland Schmieder, MD, PhD
      • Frankfurt, Tyskland
        • Rekruttering
        • Frankfurt Sankt Katharinen Krankenhaus
        • Ta kontakt med:
          • Horst Sievert, MD
      • Freiburg im Breisgau, Tyskland
        • Rekruttering
        • Freiburg Herzzenrtum
        • Ta kontakt med:
          • Elias Noory, MD
      • Hamburg, Tyskland
        • Rekruttering
        • Marienkrankenhaus Hamburg
        • Ta kontakt med:
          • Jury Schewel, MD
      • Herne, Tyskland
        • Rekruttering
        • Herne Marien Hospital
        • Ta kontakt med:
          • Christian Ukena, MD, PhD
      • Homburg, Tyskland
        • Rekruttering
        • Saarland University Hospital
        • Ta kontakt med:
          • Kulenthiran Saarraaken, MD
      • Leipzig, Tyskland
        • Rekruttering
        • Herzzentrum Leipzig
        • Ta kontakt med:
          • Karl Fengler, MD
      • Lübeck, Tyskland
        • Rekruttering
        • Sana Kliniken Lubeck
        • Ta kontakt med:
          • Joachim Weil, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

22 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: TIVUS™ Renal Denervation System

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

Andre navn:
  • Renal denervering
Sham-komparator: Sham

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reduction in average daytime ambulatory systolic BP
Tidsramme: 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)
Tidsramme: From Baseline to 30 day and 6 months post procedure

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reduction in average 24-hr ambulatory systolic BP
Tidsramme: From baseline to 2 Months post procedure

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

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

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

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

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

Secondary outcome
From baseline to 2 Months post procedure
Reduction in average office diastolic BP
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From baseline to 2, 6, and 12 Months post procedure

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reduction in average night-time ambulatory systolic/diastolic BP
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: From baseline to 2, 6, 12, 24 and 36 Months.

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

SoniVie Inc.

Samarbeidspartnere

European Cardiovascular Research Center
NAMSA
IQVIA Pty Ltd

Etterforskere

  • Studiestol: Ajay Kirtane, MD, Columbia University
  • Studiestol: Michel Azizi, MD, George Pompidou Hospital
  • Studiestol: Felix Mahfoud, MD, University of Basel

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. oktober 2024

Primær fullføring (Antatt)

31. mars 2027

Studiet fullført (Antatt)

15. august 2028

Datoer for studieregistrering

Først innsendt

24. juli 2024

Først innsendt som oppfylte QC-kriteriene

15. august 2024

Først lagt ut (Faktiske)

19. august 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLNS07-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere