Table 1.
Patient Demographics (VINDICATE) at Randomization: Intention-to-Treat Population
| Total (n = 163) | Placebo (n = 83) | Vitamin D (n = 80) | |
|---|---|---|---|
| Male | 129 (79.1) | 62 (74.7) | 67 (83.8) |
| Age, yrs | 68.7 ± 13.10 | 69.0 ± 13.78 | 68.5 ± 12.45 |
| Caucasian | 146 (90.0) | 74 (89.0) | 72 (90.0) |
| Etiology | |||
| Ischemic heart disease | 94 (57.7) | 50 (60.2) | 44 (55.0) |
| Nonischemic cardiomyopathy | 61 (37.4) | 29 (34.9) | 32 (40.0) |
| Valvular heart disease | 8 (4.9) | 4 (4.8) | 4 (5.0) |
| Diabetes mellitus | 37 (22.7) | 20 (24.1) | 17 (21.3) |
| BMI, kg/m2 | 30.0 ± 11.41 | 30.3 ± 14.36 | 29.8 ± 7.26 |
| NYHA functional class | |||
| II | 145 (89.0) | 71 (85.5) | 74 (92.5) |
| III | 18 (11.0) | 12 (14.5) | 6 (7.5) |
| Beta blockers | 155 (95.1) | 79 (95.2) | 76 (95.0) |
| ACEi/ARB | 150 (92.0) | 76 (91.6) | 74 (92.5) |
| Furosemide dose, mg/day | 61.4 ± 46.38 | 64.4 ± 52.07 | 58.6 ± 41.00 |
| Digoxin | 29 (18.0) | 15 (18.3) | 14 (17.7) |
| Spironolactone | 83 (51.2) | 41 (50.0) | 42 (52.5) |
| Device (ICD or CRT) | 48 (29.5) | 27 (32.5) | 21 (26.3) |
| Atrial fibrillation, | 68 (45.0) | 33 (42.9) | 35 (47.3) |
| Baseline heart rate, beats/min | 70.5 ± 13.10 | 72.7 ± 14.72 | 68.2 ± 10.86 |
| Systolic BP, mm Hg | 120.3 ± 20.81 | 122.9 ± 22.44 | 117.6 ± 18.74 |
| Diastolic BP, mm Hg | 71.2 ± 13.21 | 72.8 ± 14.96 | 70.0 ± 10.99 |
| 6-min walk test, m | 292.9 (120.35) | 283.7 (116.84) | 302.2 (123.81) |
| LVEF % | 26.1 ± 10.68 | 26.5 ± 10.62 | 25.6 ± 10.80 |
| LVEDD, mm | 57.8 ± 7.58 | 58.0 ± 6.49 | 57.6 ± 8.62 |
| LVESD, mm | 50.3 ± 8.50 | 50.7 ± 7.58 | 49.8 ± 9.42 |
| LVEDV, ml | 163.0 ± 66.60 | 164.1 ± 60.07 | 161.8 ± 73.58 |
| LVESV, ml | 115.4 ± 59.39 | 119.4 ± 53.30 | 111.0 ± 63.58 |
| 25(OH) Vitamin D, nmol/l | 37.3 ± 22.56 | 36.4 ± 20.24 | 38.2 ± 24.81 |
| Parathyroid hormone, pmol/l | 11.4 ± 8.09 | 11.7 ± 7.50 | 11.0 ± 8.75 |
| Creatinine, μmol/l | 96 ± 29.3 | 94.4 ± 29.42 | 96.6 ± 29.26 |
Values are n (%) or mean ± SD. Conversion factors: vitamin D nmol/l · 0.4 = ng/ml; creatinine mmol/l · 0.11 = mg/dl; calcium mmol/l · 4 = mg/dl; parathyroid hormone pmol/l · 9.4 = pg/ml.
ACEi = angiotensin-converting enzyme inhibitor; ARB = aldosterone receptor blocker; BMI = body mass index; BP = blood pressure; CRT = cardiac resynchronization therapy; ICD = implantable cardioverter defibrillator; LVEDD = left ventricular end-diastolic diameter; LVEDV = left ventricular end-diastolic volume; LVEF = left ventricular ejection fraction; LVESD = left ventricular end-systolic diameter; LVESV = left ventricular end-systolic volume; NYHA = New York Heart Association functional class; VINDICATE = VitamIN D treatIng patients with Chronic heArT failurE.