SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01418261
• Date of registration: 15/08/2011
• Prospective Registration: Yes
• Primary sponsor: Medtronic Vascular
• Public title: SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
• Scientific title: Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
• Date of first enrolment: September 2011
• Target sample size: 535
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01418261
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: George Bakris, MD
• Affiliation: Professor of Medicine, Hypertension Center Director University of Chicago Medical Center

• Name: Deepak L Bhatt, MD, MPH
• Affiliation: VA Boston Healthcare System Department of Cardiology

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Uncontrolled Hypertension

Intervention(s)

Diagnostic Test: Renal angiogram

Device: Renal denervation (Symplicity Catheter System)

Primary Outcome(s)

Change in Office Systolic Blood Pressure [Time Frame: Baseline to 6 months post-randomization]

Secondary Outcome(s)

Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [Time Frame: Baseline to 6 months]

Secondary ID(s)

IP125

Source(s) of Monetary Support

Please refer to primary and secondary sponsors