Table 3.

Enrollment Criteria for the SYMPLICITY HTN‐3 Trial

Inclusion criteria

Age ≥18 and ≤80 years at time of randomization

Stable medication regimen including full tolerated doses of 3 or more antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 2 weeks prior to screening) and no expected changes for at least 6 months

Office SBP ≥160 mm Hg based on an average of 3 blood pressure readings measured at both an initial and a confirmatory screening visit

Written informed consent

Exclusion criteria

Renal artery anatomy ineligible for treatment including:

Main renal arteries with <4 mm diameter or with <20 mm treatable length

Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney

Renal artery stenosis (>50%) or renal artery aneurysm in either renal artery

History of prior renal artery intervention including balloon angioplasty or stenting

eGFR of <45 mL/min/1.73 m2

>1 in‐patient hospitalization for a hypertensive crisis within the past year

ABPM 24 hour average SBP <135 mm Hg

≥1 episode(s) of orthostatic hypotension (reduction of SBP of ≥20 mm Hg or DBP of ≥10 mm Hg within 3 minutes of standing) coupled with symptoms within the past year or during the screening process

Pregnant, nursing, or planning to be pregnant

Chronic oxygen support or mechanical ventilation (eg, tracheostomy) required other than nocturnal respiratory support for sleep apnea

History of or currently have any of the following medical conditions:

Primary pulmonary hypertension

Type 1 diabetes mellitus

Severe cardiac valve stenosis for which a significant reduction of blood pressure is contraindicated

Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period

History of pheochromocytoma, Cushing's disease, coarctation of the aorta, hyperthyroidism, or hyperparathyroidism

Any condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol‐specified automatic blood pressure monitor (eg, arm diameter too large for the cuff, arrhythmia that interferes with automatic monitor's pulse sensing and prohibits an accurate measurement)

Any serious medical condition that may adversely affect the safety of the participant or the study (eg, patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia)

Scheduled or planned surgery or cardiovascular intervention in the next 6 months

Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow‐up requirements

Currently enrolled in another investigational drug or device trial

Abbreviations: ABPM, ambulatory blood pressure monitoring; DPB, diastolic blood pressure; eGFR, estimated glomerular filtration rate; SBP, systolic blood pressure.