SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
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|ClinicalTrials.gov Identifier: NCT01418261|
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : April 26, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Uncontrolled Hypertension||Device: Renal denervation (Symplicity Catheter System) Diagnostic Test: Renal angiogram||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||535 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||February 17, 2017|
Experimental: Renal Denervation
Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
Device: Renal denervation (Symplicity Catheter System)
Diagnostic Test: Renal angiogram
Sham Comparator: Control group
Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications
Diagnostic Test: Renal angiogram
- Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ]Primary Effectiveness Outcome Measure
- Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ]
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Individual is ≥ 18 and ≤ 80 years old at time of randomization.
- Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
- Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
- Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg
- Individual has type 1 diabetes mellitus
- Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to be pregnant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418261
|Principal Investigator:||George Bakris, MD||Professor of Medicine, Hypertension Center Director University of Chicago Medical Center|
|Principal Investigator:||Deepak L Bhatt, MD, MPH||VA Boston Healthcare System Department of Cardiology|
|Responsible Party:||Medtronic Vascular|
|Other Study ID Numbers:||
|First Posted:||August 17, 2011 Key Record Dates|
|Last Update Posted:||April 26, 2017|
|Last Verified:||April 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|