TABLE 1.
Baseline Demographic and Clinical Characteristics
| Phase I | Phase II | |||||||
|---|---|---|---|---|---|---|---|---|
| Overall (n = 66) | ΔEF ≥20%* (n = 29) | Transplant† (n = 37) | p Value‡ | Overall (n = 591) | ΔEF ≥10%* (n = 137) | ΔEF <10% (n = 454) | p Value§ | |
| Age, yrs | 60.6 ± 11.0 | 62.1 ± 13.1 | 59.4 ± 9.1 | 0.35 | 59.0 ± 15.5 | 56.9 ± 14.3 | 59.6 ± 15.8 | 0.071 |
| Female | 25 (37.9) | 12 (41.4) | 13 (35.1) | 0.60 | 169 (28.6) | 48 (35.0) | 121 (26.7) | 0.059 |
| African American | — | — | — | — | 43 (7.3) | 10 (7.3) | 33 (7.2) | 0.99 |
| Hispanic | — | — | — | — | 12 (2.0) | 4 (2.9) | 8 (1.8) | 0.40 |
| Asian | — | — | — | — | 26 (4.4) | 5 (3.6) | 21 (4.6) | 0.63 |
| Baseline EF, % | 27.8 ± 11.3 | 29.2 ± 10.7 | 26.7 ± 11.8 | 0.40 | 34.2 ± 14 | 29.0 ± 11.5 | 36.4 ± 14.6 | <0.0001 |
| NYHA functional class III-IV at baseline | 29 (43.9) | 16 (55.2) | 13 (35.1) | 0.10 | 199 (42.1) | 53 (42.0) | 146 (42.2) | 0.16 |
| Coronary disease | 18 (27.2) | 6 (20.7) | 12 (32.4) | 0.29 | 222(37.6) | 35 (25.5) | 187 (41.2) | 0.0009 |
| CABG | 9 (13.6) | 5 (17.2) | 4 (10.8) | 0.45 | 123 (20.8) | 20 (14.6) | 103 (22.7) | 0.041 |
| Atrial fibrillation | 18 (27.2) | 8 (27.6) | 10 (27.0) | 0.96 | 173 (29.3) | 40 (29.2) | 133 (29.3) | 0.98 |
| Diabetes | 19 (28.8) | 14 (48.2) | 5 (13.5) | 0.002 | 126 (21.3) | 36 (26.3) | 90 (19.8) | 0.11 |
| Hypertension | 17 (25.8) | 11 (37.9) | 6 (16.2) | 0.045 | 234 (39.6) | 55 (40.1) | 179 (39.4) | 0.88 |
| Device implant | 25 (37.9) | 9 (31.0) | 16 (43.2) | 0.31 | 305 (51.6) | 80 (58.4) | 225 (49.6) | 0.070 |
| Medications | ||||||||
| Beta-blocker | 48 (72.7) | 22 (75.9) | 26 (70.2) | 0.61 | 410 (69.4) | 127 (92.7) | 283 (62.3) | <0.0001 |
| ACE-I | 38 (57.6) | 17 (58.6) | 21 (56.8) | 0.88 | 274 (46.4) | 70 (51.1) | 204 (45.0) | 0.21 |
| ARB | 12 (18.2) | 4 (13.8) | 8 (21.6) | 0.41 | 81 (13.7) | 22 (16.1) | 59 (13.0) | 0.36 |
| Antiarrhythmic drug | 8 (12.1) | 2 (6.9) | 6 (16.2) | 0.25 | 105 (17.8) | 19 (13.9) | 86 (18.9) | 0.17 |
| CCB | 0 | 0 | 0 | — | 10 (1.7) | 5 (3.7) | 5 (1.1) | 0.0427 |
Values are mean ± SD or n (%).
ΔEF ≥20% and ≥EF >10% represent patients whose EF improved by an absolute value >20 or >10 percentage points, respectively.
Transplant patients are those with decompensation in their clinical status despite medical intervention and required heart transplantation.
p values represent significance from the Student t test for continuous variables and chi-square test for categorical variables between those with an improvement in EF by 20 percentage points and those who underwent transplant.
p value for differences between those whose EF improved by 10 percentage points and those without such an improvement.
ACE-I = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; CABG = coronary artery bypass grafting; CCB = calcium-channel blocker; EF = ejection fraction; NYHA = New York Heart Association.