Table. Clinical Profiles in the DAPA-HF Trial and GWTG-HF Registry.
| Characteristic | Patients, No. (%) | ||
|---|---|---|---|
| DAPA-HF trial population (n = 4744) | GWTG-HF registry | ||
| DAPA-HF trial eligible (n = 68 383) | FDA label candidates (n = 125 497) | ||
| Enrollment period | 2017-2018 | 2014-2019 | 2014-2019 |
| Sites | 410 Sites, 20 countries | 406 Sites across US | 406 Sites across US |
| Demographic characteristics | |||
| Age, mean (SD), y | 66 (11) | 69 (15) | 68 (15) |
| Women | 1109 (23.4) | 24 611 (36.0) | 42 016 (33.5) |
| Race/ethnicity | |||
| White | 3333 (70.3) | 42 076 (61.5) | 76 575 (61.0) |
| Black | 226 (4.8) | 17 586 (25.7) | 33 356 (26.6) |
| Asian | 1116 (23.5) | 930 (1.4) | 1616 (1.3) |
| Other | 69 (1.5) | 7791 (11.4) | 13 950 (11.1) |
| North America | 677 (14.3) | 68 383 (100) | 125 497 (100) |
| Medical history | |||
| Current smokinga | 693 (14.6) | 15 514 (22.7) | 30 022 (23.9) |
| Atrial fibrillation | 1818 (38.3) | 23 085 (33.8) | 43 894 (35.0) |
| Hypertension | 3523 (74.3) | 55 181 (80.7) | 100 645 (80.2) |
| Diabetesb | 2139 (45.1) | 28 471 (41.6) | 51 609 (41.1) |
| COPD or asthmac | 585 (12.3) | 21 321 (31.2) | 39 888 (31.8) |
| History | |||
| Myocardial infarction | 2092 (44.1) | 16 085 (23.5) | 31 059 (24.7) |
| Stroke or transient ischemic attackd | 466 (9.8) | 10 132 (14.8) | 18 729 (14.9) |
| PCI | 1624 (34.2) | 13 181 (19.3) | 26 033 (20.7) |
| CABG | 799 (16.8) | 12 939 (18.9) | 24 622 (19.6) |
| Other clinical characteristicse | |||
| Ischemic HF etiology | 2674 (56.4) | 36 554 (53.5) | 69 450 (55.3) |
| Left ventricular ejection fraction, mean (SD), % | 31 (7) | 27 (9) | 26 (9) |
| BMI, mean (SD) | 28 (6) | 29 (8) | 29 (8) |
| Systolic blood pressure, mean (SD), mm Hg | 122 (16) | 121 (18) | 118 (191) |
| Heart rate, mean (SD), beats/min | 72 (12) | 80 (16) | 80 (15) |
| eGFR, median (IQR), mL/min/1.73 m2 | 66 (20)f | 59 (45-77) | 59 (45-77) |
| Potassium, mean (SD), mEq/L | 4.5 (0.5) | 4.1 (0.5) | 4.1 (0.5) |
| Background therapiesg | |||
| ARNI | 508 (10.7) | 3793 (5.5) | 7818 (6.2) |
| ACEi or ARB | 3934 (82.9) | 44 870 (65.6) | 81 094 (64.6) |
| β-Blocker | 4558 (96.1) | 60 568 (88.6) | 110 625 (88.1) |
| MRA | 3370 (71.0) | 22 224 (32.5) | 45 039 (35.9) |
| Digoxin | 887 (18.7) | 4571 (6.7) | 10 244 (8.2) |
| Isosorbide dinitrate and hydralazine | NA | 7290 (10.7) | 13 697 (10.9) |
| Implantable cardioverter-defibrillatorh | 953 (20.1) | 14 877 (21.8) | 35 873 (28.6) |
| In-hospital outcomes and dispositioni | |||
| Hospital length of stay, median (IQR) | NA | 4 (3-6) | 4 (3-6) |
| Disposition | |||
| Death | NA | 1685 (2.5) | 2291 (1.8) |
| Hospice | NA | 967 (1.4) | 2917 (2.3) |
| Other health care facility | NA | 9704 (14.2) | 17 189 (13.7) |
| Home | NA | 55 958 (81.8) | 102 986 (82.1) |
| Missing | NA | 69 (0.1) | 114 (0.1) |
Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin-receptor neprilysin inhibitor; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; DAPA-HF, Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure; eGFR, estimated glomerular filtration rate; FDA, US Food and Drug Administration; GWTG-HF, Get With the Guidelines–Heart Failure; HF, heart failure; IQR, interquartile range; MRA, mineralocorticoid receptor antagonist; PCI, percutaneous coronary intervention.
SI conversion factor: To convert potassium to millimoles per liter, multiply by 1.0.
In GWTG-HF, this variable reflects recent history (within 12 months) or current cigarette smoking.
In both populations, this variable includes incident cases identified at screening or during hospitalization.
In DAPA-HF, this variable includes COPD alone.
In DAPA-HF, this variable includes stroke alone.
Vital signs and laboratory parameters were assessed at discharge. If not available, the closest value to discharge was considered.
Data reported as mean (SD).
Data were missing in 52 651 of 154 714 patients (34.0%) for ARNI use, 4539 of 154 714 patients (2.9%) for ACEi or ARB use, 4459 of 154 714 patients (2.9%) for β-blocker use, and 5774 of 154 714 patients (3.7%) for MRA use.
In GWTG-HF, this variable includes cardiac resynchronization therapy with defibrillator.
In-hospital outcomes and disposition were not relevant to the DAPA-HF trial population given enrollment of patients with chronic HFrEF.