Table 1.
Trial-Level Characteristics of HF Trials Published from 2001 to 2016
| Trial characteristics | Chronic HFpEF trials with >100 patients (n=16) | All Chronic HFpEF trials (n=42) | Chronic HFrEF trials (n=374) | Chronic HF regardless of EF (n=132) | Acute HF trials (n=76) | P-Value* |
|---|---|---|---|---|---|---|
| Year published | ||||||
| 2001–2008 | 5 (31) | 8 (19) | 148 (40) | 52 (40) | 30 (39) | |
| 2009–2016 | 11 (69) | 34 (81) | 226 (60) | 80 (61) | 46 (61) | 0.14 |
| Trial size, median (interquartile range) | ||||||
| Patients | 220 (147–365) | 62 (30–162) | 97.5 (41–335) | 141.5 (65–277) | 106.5 (55.5–326.5) | 0.03 |
| Sites | 39 (12–65) | 1 (1–12) | 4 (1–38) | 2 (1–7) | 8 (1–31) | 0.002 |
| Countries | 2 (1–8) | 1 (1–2) | 1 (1–2) | 1 (1–1) | 1 (1–2) | <0.001 |
| Duration (years) | 3 (2.2–4.8) | 2.3 (1.3–4.2) | 2.1 (1.42–3.33) | 1.92 (1.17–3.08) | 2 (1.17–2.74) | 0.23 |
| Enrollment rate (patient/site/month) | 0.29 (0.18–0.57) | 0.88 (0.39–2.23) | 0.61 (0.26–2.0) | 2.25 (1.13–4.23) | 0.68 (0.42–2.02) | <0.001 |
| Ejection fraction cutoff (%) | 45 (45–50) | 50 (45–50) | 40 (35–40) | - | - | <0.001 |
| Intervention | ||||||
| Device | 0 (0) | 0 (0) | 64 (17) | 3 (2) | 5 (7) | |
| Medication | 15 (94) | 34 (81) | 180 (48) | 43 (33) | 57 (75) | |
| Others | 1 (6) | 8 (19) | 93 (25) | 80 (61) | 5 (7) | <0.001 |
| Procedure | 0 (0) | 0 (0) | 23 (6) | 3 (2) | 7 (9) | |
| Surgery | 0 (0) | 0 (0) | 7 (2) | 1 (1) | 1 (1) | |
| Testing/Imaging | 0 (0) | 0 (0) | 7 (2) | 2 (2) | 1 (1) | |
| Sponsor | ||||||
| Government | 6 (38) | 17 (40) | 75 (20) | 32 (24) | 9 (12) | |
| University/Organization | 1 (6) | 10 (24) | 92 (25) | 52 (39) | 25 (33) | <0.001 |
| Industry | 9 (56) | 14 (33) | 153 (41) | 28 (21) | 32 (42) | |
| Region | ||||||
| Rest of the world | 3 (23) | 7 (18) | 60 (17) | 34 (26) | 15 (20) | 0.003 |
| Multiregional | 3 (23) | 4 (10) | 69 (19) | 5 (4) | 16 (22) | |
| North America | 3 (23) | 15 (39) | 103 (29) | 46 (35) | 23 (31) | |
| Western Europe | 4 (31) | 13 (33) | 126 (35) | 46 (35) | 20 (27) | |
| Multicenter (>3 sites) | 13 (93) | 21 (50) | 178 (50) | 47 (37) | 41 (54) | |
| Multinational | 10 (67) | 13 (32) | 112 (30) | 9 (7) | 22 (29) | <0.001 |
| Primary Outcome | ||||||
| Mortality | 4 (25) | 4 (10) | 102 (27) | 38 (29) | 12 (16) | |
| Non-mortality intermediate outcomes | 8 (50) | 21 (50) | 141 (38) | 63 (48) | 25 (33) | 0.001 |
| Surrogate outcomes | 4 (25) | 17 (40) | 130 (35) | 31 (23) | 39 (51) |
*
Comparison across trials of chronic HFpEF, chronic HFrEF, chronic HF regardless of EF, and acute HF.
Data reported as n (%) or median (interquartile range).
Abbreviations: EF = ejection fraction; HF = heart failure; HFpEF = heart failure with preserved ejection fraction; HFrEF = heart failure with reduced ejection fraction.