Table 1. Baseline Demographics and Clinical Characteristics of the Intention-to-Treat Population.
| No. (%)a | ||
|---|---|---|
| Ultrasound renal denervation (n = 150) | Sham procedure (n = 74) | |
| Age, mean (SD), y | 55.1 (9.9) | 54.9 (7.9) |
| Sex | ||
| Female | 47 (31.3) | 17 (23.0) |
| Male | 103 (68.7) | 57 (77.0) |
| Raceb | ||
| Black or African American | 21 (14.0) | 15 (20.3) |
| White | 114 (76.0) | 56 (75.7) |
| Other/multiple racesc | 15 (10.0) | 3 (4.1) |
| Body mass index, mean (SD)d | 30.1 (5.2) | 30.6 (5.2) |
| Abdominal obesitye | 90 (60.0) | 46 (62.2) |
| Estimated glomerular filtration rate | ||
| Mean (SD), mL/min/1.73 m2 | 81.4 (14.4) | 82.3 (14.9) |
| <60 mL/min/1.73 m2 | 7 (4.7) | 3 (4.1) |
| Type 2 diabetes | 9 (6.0) | 5 (6.8) |
| Sleep apnea syndrome | 21 (14.0) | 13 (17.6) |
| Prior hospitalization for hypertensive crisis | 9 (6.0) | 3 (4.1) |
| History of heart failure | 1 (0.7) | 0 |
| Blood pressure at office screening, mean (SD), mm Hg | ||
| Systolic | 155.8 (11.1) | 154.3 (10.6) |
| Diastolic | 101.3 (6.7) | 99.1 (5.6) |
| Heart rate at office screening, mean (SD), beats/min | 74.1 (12.0) | 73.6 (11.9) |
| Not taking antihypertensive medications at screening | 54 (36.0) | 23 (31.1) |
| Taking antihypertensive medications at screening | ||
| 1 Medication | 52 (34.7) | 25 (33.8) |
| 2 Medications | 44 (29.3) | 25 (33.8) |
| >2 Medications | 0 | 1 (1.4)f |
| Type of antihypertensive medication at screening in patients taking medications | (n = 96) | (n = 51) |
| Renin-angiotensin system blockers | 73 (76.0) | 35 (68.6) |
| Calcium channel blockers | 28 (29.2) | 22 (43.1) |
| Diuretics | 25 (26.0) | 13 (25.5) |
| β-Blockers | 10 (10.4) | 5 (9.8) |
| Aldosterone antagonists | 1 (1.0) | 1 (2.0) |
| Otherg | 3 (3.1) | 3 (5.9) |
a
Unless otherwise indicated.
b
Identified by direct questioning of the participant with specific categories the patient could select.
c
There were 15 patients in the ultrasound renal denervation group and 2 patients in the sham procedure group who selected the category “other/multiple races.” One patient selected another category but because there were fewer than 5 patients in that category, that patient is listed with “other.”
d
Calculated as weight in kilograms divided by height in meters squared.
e
Defined as a waist circumference greater than 102 cm for men and greater than 88 cm for women.
f
One patient was discovered to be taking 4 medications after randomization.
g
Included α1 receptor blockers, centrally acting drugs, and vasodilators.