Trial | AASK | HALT-PKD | MDRD | REIN-2 | SPRINT | Total |
Date of publication | 2002 | 2014 | 1994 | 2005 | 2017 | 1994–2017 |
Number of patients included | 1094 | 178 | 840 | 335 | 2554 | 5001 |
GFR criteria (mL/min/1.73 m2) | 20–65 | >60 | 13–55 | <70, excluding ESRD | 20–59 | <60 or ≥60 with abnormal albuminuria or proteinuria |
GFR assessment method | Renal clearance of 125I-iothalamate | eGFR from SCr | Renal clearance of 125I-iothalamate | Renal clearance of non-radioactive iohexol | eGFR from SCr | (per trial) |
Albuminuria/proteinuria criteria | UPCR ≤2.5 g/g | UAER ≥30 mg/day | UPER <10 g/day | UPER ≥1 g/day | UACR <600 mg/g | (per trial) |
Standard BP target (mm Hg) | MAP 102–107 (≈140/90) | 120–130/70–80 | MAP ≤107 (≈140/90) | DBP <90 | SBP <140 | (per trial) |
Intensive BP intervention (mm Hg) | MAP ≤92 (≈125/75) | 95–110/60–75 | MAP ≤92 (≈125/75) | <130/80 | SBP <120 | (per trial) |
Intensive treatment, n (%) | 540 (49.4) | 91 (51.1) | 432 (51.4) | 167 (49.9) | 1284 (50.3) | 2514 (50.3) |
Age, years | 54.1±10.7 | 35.7±8.3 | 51.3±12.4 | 53.5±15.3 | 71.9±9.3 | 62.0±15.0 |
Female sex, n (%) | 424 (38.8) | 83 (46.6) | 332 (39.5) | 84 (25.1) | 1005 (39.4) | 1928 (38.6) |
Race or ethnicity, n (%) | ||||||
Non-Hispanic black | 1094 (100.0) | 7 (3.9) | 66 (7.9) | 0 (0.0) | 616 (24.1) | 1783 (35.7) |
Non-Hispanic white | 0 (0.0) | 162 (91.0) | 714 (85.0) | 331 (98.8) | 1715 (67.1) | 2922 (58.4) |
Hispanic | 0 (0.0) | 3 (1.7) | 39 (4.6) | 0 (0.0) | 183 (7.2) | 225 (4.5) |
Other | 0 (0.0) | 6 (3.4) | 21 (2.5) | 4 (1.2) | 40 (1.6) | 71 (1.4) |
BMI, kg/m2 | 30.6±6.6 | 27.2±5.4 | 27.1±4.4 | 26.4±4.3 | 29.4±5.8 | 29.0±5.8 |
Comorbidities, n (%) | ||||||
HTN | 1094 (100) | 178 (100) | 724 (86.2) | 335 (100) | 2554 (100) | 4885 (97.7) |
DM | 0 (0) | 0 (0) | 43 (5.1) | 0 (0) | 0 (0) | 43 (0.9) |
CVD | 564 (51.6) | 0 (0) | 81 (9.6) | 80 (23.9) | 627 (24.5) | 1352 (27) |
Smoking status, n (%) | ||||||
Never smoked | 461 (42.1) | 103 (57.9) | 400 (47.6) | 196 (58.5) | 1161 (45.5) | 2321 (46.4) |
Former smoker | 312 (28.5) | 51 (28.7) | 82 (9.8) | 81 (24.2) | 1176 (46.0) | 1702 (34.0) |
Current smoker | 321 (29.3) | 24 (13.5) | 358 (42.6) | 54 (16.1) | 216 (8.5) | 973 (19.5) |
Missing data | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (1.2) | 1 (0.0) | 5 (0.1) |
Baseline BP, mm Hg | ||||||
Systolic | 150.3±23.9 | 127.9±14.9 | 131.9±17.6 | 136.7±16.9 | 139.1±16.0 | 139.8±19.3 |
Diastolic | 95.5±14.2 | 81.3±10.9 | 81.0±10.1 | 84.1±9.7 | 75.0±12.2 | 81.3±14.6 |
Number of follow-up BP readings evaluated | 12,344 | 1850 | 6889 | 2169 | 22,882 | 46,134 |
Number of antihypertensive agents | ||||||
At baseline | 2.4±1.2 | 0.2±0.5 | 1.6±1.1 | 2.0±1.1 | 2.1±1.0 | 2.0±1.1 |
In standard BP arm | 2.1±0.9 | 1.6±0.7 | 1.7±1.2 | 2.2±1.2 | 2.2±1.1 | 2.1±0.2 |
In intensive BP arm | 2.2±1.0 | 1.7±0.8 | 1.6±1.2 | 3.0±1.0 | 2.5±1.0 | 2.3±1.1 |
Mean follow-up SBP, mm Hg* | ||||||
In standard BP arm | 141.2±12.8 | 120.5±9.1 | 134.4±15.9 | 134.7±14.4 | 136.0±9.2 | 136.3±6.7 |
In intensive BP arm | 129.4±13.7 | 113.3±11.3 | 127.1±14.3 | 130.8±12.0 | 123.3±10.2 | 125.4±12.5 |
Mean follow-up DBP, mm Hg* | ||||||
In standard BP arm | 85.7±7.9 | 77.6±7.0 | 81.0±7.2 | 82.5±7.6 | 72.6±10.0 | 77.8±3.8 |
In intensive BP arm | 78.2±9.2 | 71.6±8.8 | 77.4±6.8 | 79.8±6.1 | 66.3±9.1 | 71.8±10.4 |
Baseline GFR, mL/min/1.73 m2 | 46.4±13.6 | 77.7±19.4 | 33.0±11.7 | 29.1±15.8 | 47.8±9.5 | 44.8±14.9 |
Median baseline albuminuria, mg/day or mg/g (IQR) | 49.9 (33.1–91.0) | 13.3 (6.4–43.0) | 14.7 (6.7–48.5) | |||
Median baseline proteinuria, mg/day or mg/g (IQR) | 80.8 (29.8–358.8) | 320.0 (70.0–1502.5) | 1923.6 (1178.1–2849.7) | 233.9 (50.0–1250.0) | ||
Median follow-up, years | 4.2 | 6.0 | 2.7 | 1.6 | 3.2 | 3.2 |
Lost to follow-up or withdrawal, n (%)† | 9 (0.8) | 36 (20.2) | 16 (1.9) | 49 (14.6) | 126 (4.9) | 236 (4.7) |
Completed study, n (%) | 980 (89.6) | 141 (79.2) | 790 (94.0) | 281 (83.9) | 2266 (88.7) | 4458 (89.1) |
Outcomes, n (%) | ||||||
CKD progression‡ | 300 (27.4) | 1 (0.6) | 298 (35.5) | 86 (25.7) | 28 (1.1) | 713 (14.3) |
GFR decrease by ≥50% | 243 (22.2) | 0 (0.0) | 237 (28.2) | 53 (15.8) | 20 (0.8) | 553 (11.1) |
ESRD or transplant | 179 (16.4) | 1 (0.6) | 194 (23.1) | 72 (21.5) | 16 (0.6) | 462 (9.2) |
Death | 105 (9.6) | 1 (0.6) | 34 (4.0) | 5 (1.5) | 162 (6.3) | 307 (6.1) |
AKI | 20 (1.8) | 14 (7.9) | 2 (0.2) | 0 (0.0) | 190 (7.4) | 226 (4.5) |
Numerical data are reported as mean±SD, unless otherwise specified.
*Defined as mean of all follow-up values beginning 6 months after randomization; if not available then the last known BP was used.
†Excludes patients who died.
‡Composite of ≥50% reduction in GFR from baseline or ESRD requiring RRT (long-term dialysis or renal transplantation).
AASK, African American Study of Kidney Disease and Hypertension; AKI, acute kidney injury; BMI, body mass index; BP, blood pressure; CKD, chronic kidney disease; CVD, cardiovascular disease; DBP, diastolic blood pressure; DM, diabetes mellitus; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease; GFR, glomerular filtration rate; HALT-PKD, HALT Progression of Polycystic Kidney Disease; HTN, hypertension; MAP, mean arterial pressure; MDRD, Modification of Diet in Renal Disease; REIN-2, Ramipril Efficacy In Nephropathy 2; RRT, renal replacement therapy; ; SBP, systolic blood pressure; SCr, serum creatinine; SPRINT, Systolic Blood Pressure Intervention Trial; UACR, urine albumin to creatinine ratio; UAER, urine albumin excretion rate; UPCR, urine protein to creatinine ratio; UPER, urine protein excretion rate.