Status:
RECRUITING
THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
Lead Sponsor:
SoniVie Inc.
Collaborating Sponsors:
NAMSA
European Cardiovascular Research Center
Conditions:
Hypertension
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
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 hypertension (HTN) receiving up to 2 anti-hype...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Evidence of active infection within 7 days of procedure (based on positive lab test and requiring therapy).
- Subject has hypertrophic cardiomyopathy or amyloidosis.
- Prior renal denervation procedure
- Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional studies/registries is acceptable)
- Subject on a beta blocker for a condition other than antihypertension
- Angiographic
Key Trial Info
Start Date :
October 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2028
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT06559891
Start Date
October 3 2024
End Date
August 15 2028
Last Update
December 31 2025
Active Locations (44)
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1
Cardiology, PC
Birmingham, Alabama, United States, 35211
2
Honor Health Research Institue
Scottsdale, Arizona, United States, 85258
3
St. Bernard's Medical Center
Jonesboro, Arkansas, United States, 72401
4
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211