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Compares treatment options for Hypertension
Official title THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
ClinicalTrials.gov ID: NCT06559891
What this study is testing
- What it's testing
- 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.
- Time commitment: about 2 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join 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:
You likely can't join if
- Subject has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as a single kidney, ectopic or horseshoe kidney...
- Uncorrected causes of secondary hypertension other than sleep apnea (including, but not limited to): aldosteronism, renal parenchymal disease...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- Able and willing to comply with all study procedures
- Subject is willing to have and is a good candidate for conscious sedation people 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 people without a recent...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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-treatment studies/registries is acceptable)
- 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...
- Main renal arteries lumen diameter \< 4 mm.
- Main renal treatable artery length \<20mm (may include proximal branching).
- Accessory renal arteries that supplies ≥ 25% of the parenchyma, and \< 4 mm in lumen diameter.
- Aorto-renal angle that prevents a safe cannulation of the renal artery.
- 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.
- 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...
- Any renal artery stenosis \> 30% by visual assessment.
- Any renal artery aneurysm (\>50% of the main renal artery reference vessel diameter by visual estimate).
- Presence of fibromuscular dysplasia of the renal arteries
- Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Bridgeport, Connecticut, United States
- Pensecola, Florida, United States
- Tampa, Florida, United States
- Elk Grove Village, Illinois, United States
- Springfield, Illinois, United States
- Houma, Louisiana, United States
- New Orleans, Louisiana, United States
- Detroit, Michigan, United States
- Southfield, Michigan, United States
- Gulfport, Mississippi, United States
- Jackson, Mississippi, United States
- Kansas City, Missouri, United States
- Reno, Nevada, United States
- Camden, New Jersey, United States
+ 29 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Palo Alto, California, United States and 43 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.