Research Study: Symplicity HTN-3 Renal Denervation (RDN) in Patients with Uncontrolled Hypertension

Objective

In people with hypertension, the renal nerves (which communicate information from the kidney to the brain) are hyperactive. This hyperactivity raises blood pressure, which in turn contributes to heart, kidney, and blood vessel damage.

There is an investigational method for high blood pressure designed to target the nerves in the renal arteries. The Symplicity HTN-3 study aims to learn whether treating blood pressure by targeting nerves in the renal arteries is more effective than medications alone for patients with resistant high blood pressure.

All Other Trials

• Heart & Circulation
• Kidneys & Urinary

Contact

Christina Schmitt, BS at 303-724-2098
or Christina.schmitt@ucdenver.edu

Eligibility and Other Participant Information

Inclusion critera

• Age 18-80 at randomization
• On stable medication regimen, including full tolerated doses of ≥3 antihypertensive medications of different classes, one of which must be a diuretic (with no changes for a minimum of two weeks prior to screening), that is expected to be maintained without changes for at least six months
• Office systolic blood pressure ≥160 mmHg based on an average of three blood pressure readings measured at both an initial screening visit and confirmatory screening visits

Exclusion criteria

• Renal artery anatomy that is ineligible for treatment
• Ambulatory blood pressure monitoring (ABPM) 24-hour average systolic blood pressure <135 mmHg
• eGFR <45mL/min/1.73m² using the MDRD calculation
• >1 in-patient hospitalization for a hypertensive crisis within the past year
• Type 1 diabetes mellitus
• Pregnant, nursing, or planning to become pregnant