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Renal Denervation for High Blood Pressure
N/A
Waitlist Available
Led By Raymond Townsend, MD
Research Sponsored by Medtronic Vascular
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) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
Be older than 18 years old
Must not have
Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 1 month post-procedure (6 months for new renal artery stenosis)
Awards & highlights
Summary
This trial is testing whether a kidney surgery can lower blood pressure when done alongside other blood pressure medications.
Who is the study for?
This trial is for adults with high blood pressure (140-170 mmHg over 24 hours, or office SBP of 150-180 mmHg and DBP ≥ 90 mmHg) while on up to three blood pressure medications. It's not for those with severe kidney issues, recent heart problems, certain vascular conditions, poor renal anatomy, chronic pain treated with NSAIDs often, pregnant/nursing women, uncontrolled diabetes, orthostatic hypotension or night shift workers.
What is being tested?
The SPYRAL HTN-ON MED Study is testing if the Symplicity Spyral™ renal denervation system can safely lower blood pressure compared to a sham procedure in patients already taking up to three antihypertensive drugs.
What are the potential side effects?
Potential side effects may include reactions related to the catheter-based procedure such as bleeding or bruising at the access site, damage to the kidney arteries or nerves around them; however specific risks will be detailed by study staff.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is high even though I am on 1-3 blood pressure medications.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need oxygen or a ventilator to breathe, not just for sleep apnea at night.
Select...
I have type 1 diabetes or my type 2 diabetes is not well-controlled.
Select...
I have experienced dizziness upon standing up.
Select...
I have had heart issues or a stroke within the last 3 months or have atrial fibrillation.
Select...
My kidney arteries are not suitable for the procedure.
Select...
I have high blood pressure in the lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 1 month post-procedure (6 months for new renal artery stenosis)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 1 month post-procedure (6 months for new renal artery stenosis)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Secondary study objectives
Antihypertensive Medication Burden to 6-months
Antihypertensive Medication Usage and Changes to 6-months
Change in Office Systolic Blood Pressure
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Renal DenervationExperimental Treatment1 Intervention
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Group II: Sham ProcedurePlacebo Group1 Intervention
Renal angiography
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Symplicity Spyral™ multi-electrode renal denervation system
2015
N/A
~370
Find a Location
Who is running the clinical trial?
Medtronic VascularLead Sponsor
65 Previous Clinical Trials
55,925 Total Patients Enrolled
Raymond Townsend, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
457 Total Patients Enrolled
David Kandzari, MDPrincipal InvestigatorPiedmont Hospital
17 Previous Clinical Trials
8,006 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need oxygen or a ventilator to breathe, not just for sleep apnea at night.I regularly take painkillers for ongoing pain.I have type 1 diabetes or my type 2 diabetes is not well-controlled.You work during the night.I have experienced dizziness upon standing up.I have had heart issues or a stroke within the last 3 months or have atrial fibrillation.My kidney arteries are not suitable for the procedure.I have high blood pressure in the lungs.My blood pressure is high even though I am on 1-3 blood pressure medications.
Research Study Groups:
This trial has the following groups:- Group 1: Renal Denervation
- Group 2: Sham Procedure
Awards:
This trial has 0 awards, including: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.
High Blood Pressure Patient Testimony for trial: Trial Name: NCT02439775 — N/A
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