THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Hypertension

In brief

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

Key facts

Study ID

NCT06559891

Run by

SoniVie Inc.

People needed

261

Starts

2024-10-03

Expected to finish

2028-08-15

Last updated by the study team

2026-08-03

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Appropriately signed and dated informed consent
• Male and female adults with age between ≥22 and ≤75 years at time of consent
• Documented history of hypertension
• Previously or currently prescribed antihypertensive therapy
• Subject has an office BP (average of 3 seated measurements) of:
• 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,
• 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
• Able and willing to comply with all study procedures
• 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.

You may not qualify if…

• 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
• 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)
• Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥ 9.0%)
• eGFR of <40 mL/min/1.73 m2 CKD-EPI as calculated using the CKD-EPI 2021 equation
• Cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 6 months prior to consent
• 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
• Subject has severe valvular stenosis or insufficiency
• 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
• 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
• Subject with rapid, uncontrolled, symptomatic atrial fibrillation
• Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
• Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
• Subject has a planned major surgery (any procedure requiring general anesthesia) in the next 12 months.
• Subject on anticoagulant therapy that cannot be temporarily withheld for study procedure.
• Primary pulmonary hypertension
• Documented contraindication or allergy to contrast medium not amenable to treatment
• Limited life expectancy of < 1 year at the discretion of the Investigator
• Night shift worker
• 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.
• Subject is taking immunosuppressive therapy for diseases featuring vasculitis
• 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
• 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
• Subject has a planned major surgery or cardiovascular intervention in the next 6 months
• Subject with history of renal transplantation

Where it is running

• Cardiology, PC — Birmingham, Alabama, United States (enrolling)
• HonorHealth — Scottsdale, Arizona, United States (enrolling)
• St. Bernard's Medical Center — Jonesboro, Arkansas, United States (enrolling)
• Arkansas Heart Hospital — Little Rock, Arkansas, United States (enrolling)
• Cedar-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Connecticut Clinical Research, LLC (Bridgeport) — Bridgeport, Connecticut, United States (enrolling)
• Ascension- Sacred Heart — Pensecola, Florida, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Ascension Alexian Brothers — Elk Grove Village, Illinois, United States (enrolling)
• St. John's Prairie Heart — Springfield, Illinois, United States (enrolling)
• Southern Illinois University, School of Medicine — Springfield, Illinois, United States (enrolling)
• Cardiovascular Institute of the South — Houma, Louisiana, United States (enrolling)
• Ochsner Medical Center — New Orleans, Louisiana, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Henry Ford Providence Hospital — Southfield, Michigan, United States (enrolling)
• Gulfport Memorial Hospital — Gulfport, Mississippi, United States (enrolling)
• Jackson Heart Clinic — Jackson, Mississippi, United States (enrolling)
• St Lukes Hospital — Kansas City, Missouri, United States (enrolling)
• Renown Regional Medical Center — Reno, Nevada, United States (enrolling)
• Virtua Health — Camden, New Jersey, United States (enrolling)
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States (enrolling)
• St. Joseph — Liverpool, New York, United States (enrolling)
• Nyph/Cumc — New York, New York, United States (enrolling)
• NC Heart and Vascular — Raleigh, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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