Table 1.
Baseline characteristics of the substudy population (included set) vs. the population of the main SHIFT study6 (randomized set)
| SHIFT echocardiography substudy |
Main study (n = 6505) | |||
|---|---|---|---|---|
| Ivabradine (n = 304) | Placebo (n = 307) | All (n = 611) | ||
| Demographic parameters | ||||
| Age (years) | 60.4 ± 10.9 | 59.1 ± 11.1 | 59.7 ± 11.0 | 60.4 ± 11.4 |
| Sex (male) | 244 (80%) | 252 (82%) | 496 (81%) | 4970 (76%) |
| Caucasian | 276 (91%) | 281 (92%) | 557 (91%) | 5771 (89%) |
| Current smoker | 48 (16%) | 48 (16%) | 96 (16%) | 1118 (17%) |
| BMI (kg/m2) | 27.7 ± 4.5 | 27.7 ± 4.9 | 27.7 ± 4.7 | 28.0 ± 5.1 |
| Cardiac parameters | ||||
| Heart rate (bpm) | 78.4 ± 9.0 | 78.8 ± 9.2 | 78.6 ± 9.1 | 79.9 ± 9.6 |
| Heart rate ≥77 bpm | 137 (45%) | 129 (42%) | 266 (44%) | 3357 (52%) |
| Sitting SBP (mm Hg) | 120.5 ± 15.9 | 119.1 ± 15.4 | 119.8 ± 15.6 | 121.7 ± 16.0 |
| Sitting DBP (mm Hg) | 75.2 ± 9.3 | 75.4 ± 9.0 | 75.3 ± 9.1 | 75.7 ± 9.5 |
| eGFR (MDRD formula) (mL/min/1.73 m2) | 73.7 ± 20.6 | 75.8 ± 25.3 | 74.7 ± 23.1 | 74.7 ± 23.0 |
| NYHA class | ||||
| Class II | 146 (48%) | 140 (46%) | 286 (47%) | 3169 (49%) |
| Class III | 156 (51%) | 164 (53%) | 320 (52%) | 3223 (50%) |
| Class IV | 2 (0.7%) | 3 (1.0%) | 5 (0.8%) | 111 (1.7%) |
| Medical history | ||||
| Duration of heart failure (years) | 3.5 ± 4.0 | 3.5 ± 4.5 | 3.5 ± 4.3 | 3.5 ± 4.2 |
| Primary cause of heart failure | ||||
| Ischaemic | 205 (67%) | 200 (65%) | 405 (66%) | 4418 (68%) |
| Non-ischaemic | 99 (33%) | 107 (35%) | 206 (34%) | 2087 (32%) |
| Myocardial infarction | 180 (59%) | 178 (58%) | 358 (59%) | 3666 (56%) |
| Hypertension | 179 (59%) | 175 (57%) | 354 (58%) | 4314 (66%) |
| Diabetes | 96 (32%) | 98 (32%) | 194 (32%) | 1979 (30%) |
| Previous stroke | 25 (8%) | 28 (9%) | 53 (9%) | 522 (8%) |
| History atrial fibrillation and/or atrial flutter | 18 (6%) | 20 (7%) | 38 (6%) | 522 (8%) |
| Left bundle branch block | 45 (15%) | 40 (13%) | 85 (14%) | 865 (13%) |
| Treatment at randomization | ||||
| β-blocker | 281 (92%) | 281 (92%) | 562 (92%) | 5820 (90%) |
| ACE inhibitor | 243 (80%) | 255 (83%) | 498 (82%) | 5116 (79%) |
| ARB | 51 (17%) | 36 (12%) | 87 (14%) | 927 (14%) |
| Diuretic (excluding antialdosterone) | 264 (87%) | 266 (87%) | 530 (87%) | 5414 (83%) |
| Aldosterone antagonist | 224 (74%) | 218 (71%) | 442 (72%) | 3922 (60%) |
| Digitalis | 83 (27%) | 99 (32%) | 182 (30%) | 1416 (22%) |
| Devices | ||||
| At least one device | 10 (3%) | 13 (4%) | 23 (4%) | 244 (4%) |
| ICD | 9 (3%) | 11 (4%) | 20 (3%) | 207 (3%) |
Data are numbers of patients (%) or means ± SD.
BMI, body mass index; bpm, beats per minute; SBP, systolic blood pressure; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; NYHA, New York Heart Association; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; ICD, implantable cardioverter defibrillator; MDRD, Modification of Diet in Renal Disease Study equation.