Table 2. Baseline Clinical Features of Patients Enrolled in PARALLAX-HF .
| No. (%) of patients | ||
|---|---|---|
| Sacubitril/valsartan (n = 1281) | Background medication–based individualized comparator (n = 1285) | |
| Clinical features of HF | ||
| NYHA class at randomizationa | ||
| Class I | 1 (0.1) | 4 (0.3) |
| Class II | 858 (67.0) | 876 (68.2) |
| Class III | 416 (32.5) | 401 (31.2) |
| Class IV | 5 (0.4) | 4 (0.3) |
| NT-proBNP, median (IQR), pg/mL | 786.0 (415.0-1401.0) | 760 (380.0-1398.0) |
| LVEF, % (SD) | 56.7 (8.3) | 56.2 (8.0) |
| Ischemic HF etiology | 444 (34.7) | 448 (34.9) |
| LVEF subgroups | ||
| Type of HF | ||
| HFpEF (EF≥50%) | 1029 (80.3) | 1036 (80.6) |
| HFmrEF (40%<EF<50%) | 252 (19.7) | 249 (19.4) |
| Type of HF among women | ||
| HFpEF (EF≥50%) | 566/643 (88.0) | 581/658 (88.3) |
| HFmrEF (40%<EF<50%) | 77/643 (12.0) | 77/658 (11.7) |
| Type of HF among men | ||
| HFpEF (EF≥50%) | 463/638 (72.6) | 455/627 (72.6) |
| HFmrEF (40%<EF<50%) | 175/638 (27.4) | 172/627 (27.4) |
| Medical history | ||
| Hypertension | 1241 (96.9) | 1251 (97.4) |
| Dyslipidemia | 869 (67.8) | 850 (66.2) |
| Atrial fibrillation or flutter | 699 (54.6) | 692 (53.9) |
| Coronary artery disease | 686 (53.6) | 682 (53.1) |
| Chronic kidney diseaseb | 636 (49.7) | 626 (48.7) |
| Diabetesc | 566 (44.2) | 589 (45.8) |
| Prior HF hospitalization | 446 (34.9) | 459 (35.7) |
| Myocardial infarction | 295 (23.0) | 306 (23.8) |
| Treatment | ||
| Diureticsd | 1277 (99.8) | 1282 (99.8) |
| ACE/ARB (prestudy) | 1115 (87.1) | 1124 (87.5) |
| β-Blockers | 1071 (83.7) | 1066 (83.0) |
| Calcium channel blockers | 444 (34.7) | 479 (37.3) |
| MRAs | 419 (32.7) | 392 (30.5) |
| SGLT-2 inhibitors | 34 (2.7) | 26 (2.0) |
Abbreviations: ACE, angiotensin converting enzyme; ARB, angiotensin II receptor blocker; HF, heart failure; HFmrEF, HF with mildly reduced ejection fraction; HFpEF, HF with preserved ejection fraction; MRA, mineralocorticoid receptor antagonist; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; SGLT-2, sodium glucose co-transporter-2.
a
NYHA is a graded class of functional capacity. Class I indicates no symptoms or limitations in ordinary physical activity; class II, dyspnea with moderate exertion; class III, dyspnea with mild exertion; and class IV, dyspnea at rest.
b
Estimated glomerular filtration rate of 60 mL/min/1.73 m2 or lower.
c
Hemoglobin A1c 6.5% or higher at screening.
d
Includes MRAs.