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Procedure
Renal Denervation for High Blood Pressure (REDUCED Trial)
N/A
Waitlist Available
Led By Ajay Kirtane, MD
Research Sponsored by SoniVie Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individual has office systolic blood pressure (SBP) ≥ 140 mm Hg but < 180 mm Hg, and a diastolic blood pressure (DBP) ≥ 90 mm Hg but < 110 mm Hg based on an average of 3 office seated blood pressure readings measured by a manual, automated or semi-automated validated BP monitor, on current medications
Patient is either on at least one anti-hypertensive medication at maximal tolerated dose with a medically documented intolerance to one or more medications, or on three medications where one is a diuretic
Must not have
Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram
Patient has valvular stenosis with risk of cardiac event with significant and/or abrupt decline in systolic blood pressure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 24, 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial studies a device to treat uncontrolled high blood pressure, assessing safety and effectiveness over 3 months.
Who is the study for?
This trial is for adults aged 18-80 with stage 2 hypertension, who have high blood pressure despite taking medication. Participants should be willing to maintain their current medication regimen and comply with study procedures. Pregnant women, individuals planning major surgeries, those on certain anticoagulants or with severe kidney issues are excluded.
What is being tested?
The REDUCED 1 trial tests the TIVUS™ System's safety and effectiveness in lowering blood pressure through renal denervation—a procedure that disrupts nerve signals contributing to high blood pressure. The focus is on changes in daytime systolic blood pressure after three months.
What are the potential side effects?
While specific side effects aren't listed here, renal denervation may cause discomfort at the catheter insertion site, bleeding complications, negative reactions to contrast dye used during the procedure, and potential impacts on kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is high but not extremely high, and I am on medication for it.
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I am on the highest dose of my blood pressure medication that I can tolerate, or I am on three medications including a water pill.
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I am between 18 and 80 years old.
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My blood pressure is high but not extremely high, even with medication.
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I am between 18 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney arteries have significant blockage or bulging as seen on a CT scan.
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I have a heart valve problem that could worsen with sudden blood pressure drops.
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I have a bleeding condition that is not well-controlled.
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I have a unique kidney shape or condition that prevents certain kidney treatments.
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I have high blood pressure due to an untreated condition.
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I have a history of serious heart or blood vessel problems.
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I cannot take certain medications or contrast dyes for a procedure, even with pre-medication.
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I am on blood thinners that cannot be stopped for a study procedure.
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I have a heart or lung condition that needs constant oxygen support.
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I have been diagnosed with fibromuscular dysplasia.
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I have a fast, irregular heartbeat that isn't well-managed.
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I have had a kidney transplant or will have one within a year.
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I have severe artery hardening or twisting that could make a specific heart procedure unsafe.
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I have undergone a kidney nerve ablation procedure.
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I have used a device to treat high blood pressure in the last 5 years.
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I have been taking pain relief medication like ibuprofen regularly for the last month.
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My kidney arteries are the right size for the study.
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I am on medication to suppress my immune system due to vasculitis.
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I have had severe dizziness upon standing up in the past year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12, 24, 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, 24, 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in mean daytime ambulatory systolic BP
Incidence of Adverse Events
Secondary study objectives
Change in mean 24-hr ambulatory diastolic bp
Change in mean 24-hr ambulatory pulse
Change in mean 24-hr ambulatory systolic and diastolic bp
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Renal denervationExperimental Treatment1 Intervention
Denervating the sympathetic nerves surrounding the renal vasculature using unfocused ultrasound
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal denervation
2012
Completed Phase 3
~160
Find a Location
Who is running the clinical trial?
SoniVie Inc.Lead Sponsor
5 Previous Clinical Trials
511 Total Patients Enrolled
Ajay Kirtane, MDPrincipal InvestigatorColumbia University/NYPH
7 Previous Clinical Trials
3,200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had an infection in the week before my procedure.My average daytime blood pressure is between 135 and 179 mm Hg after a month of monitoring.My average daytime blood pressure is between 135 and 179 mm Hg after a month of monitoring.I have a heart valve problem that could worsen with sudden blood pressure drops.I have not had major surgery or heart-related procedures in the last 3 months.I have a bleeding condition that is not well-controlled.My blood pressure is high but not extremely high, and I am on medication for it.You have a blockage of more than 30% in your kidney's blood vessels.I have a unique kidney shape or condition that prevents certain kidney treatments.I have high blood pressure due to an untreated condition.You have had a kidney stent or angioplasty in the past.My kidney arteries have significant blockage or bulging as seen on a CT scan.You have Type 1 diabetes or your Type 2 diabetes is not well controlled (your HbA1c is higher than 9%).You work overnight.I am on the highest dose of my blood pressure medication that I can tolerate, or I am on three medications including a water pill.I have a history of serious heart or blood vessel problems.I cannot take certain medications or contrast dyes for a procedure, even with pre-medication.I am willing to stick to my blood pressure medication for at least 3 months.My kidneys' blood vessels are not suitable for safe medical procedures due to their condition.I have signed the consent form to participate in this study.I have a major surgery or heart procedure planned within 6 months.I am on blood thinners that cannot be stopped for a study procedure.I have a heart or lung condition that needs constant oxygen support.I am between 18 and 80 years old.I am on the highest dose of my blood pressure medication that I can tolerate, or I am on three medications including a diuretic for my blood pressure.Your kidney function, measured as eGFR, is less than 40mL/min/1.73m2 according to a specific calculation.I have been diagnosed with fibromuscular dysplasia.I am willing to stick to my blood pressure medication plan for at least 3 months.My doctor thinks it's unsafe to insert a tube into my kidney artery due to its angle.Your average daytime blood pressure is higher than 180 mm Hg for systolic blood pressure.I have a fast, irregular heartbeat that isn't well-managed.I have had a kidney transplant or will have one within a year.You are expected to live less than 1 year.I have severe artery hardening or twisting that could make a specific heart procedure unsafe.You have a large bulge in your kidney artery.I have undergone a kidney nerve ablation procedure.I have used a device to treat high blood pressure in the last 5 years.I have been taking pain relief medication like ibuprofen regularly for the last month.My kidney arteries are the right size for the study.I am on medication to suppress my immune system due to vasculitis.I have had severe dizziness upon standing up in the past year.My blood pressure is high but not extremely high, even with medication.I am between 18 and 80 years old.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Renal denervation
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