Effect of paricalcitol on left ventricular mass and function in CKD--the OPERA trial.
Vitamin D seems to protect against cardiovascular disease, but the reported effects of vitamin D on patient outcomes in CKD are controversial. We conducted a prospective, double blind, randomized, placebo-controlled trial to determine whether oral activated vitamin D reduces left ventricular (LV) mass in patients with stages 3-5 CKD with LV hypertrophy. Subjects with echocardiographic criteria of LV hypertrophy were randomly assigned to receive either oral paricalcitol (1 μg) one time daily (n=30) or matching placebo (n=30) for 52 weeks. The primary end point was change in LV mass index over 52 weeks, which was measured by cardiac magnetic resonance imaging. Secondary end points included changes in LV volume, echocardiographic measures of systolic and diastolic function, biochemical parameters of mineral bone disease, and measures of renal function. Change in LV mass index did not differ significantly between groups (median [interquartile range], -2.59 [-6.13 to 0.32] g/m(2) with paricalcitol versus -4.85 [-9.89 to 1.10] g/m(2) with placebo). Changes in LV volume, ejection fraction, tissue Doppler-derived measures of early diastolic and systolic mitral annular velocities, and ratio of early mitral inflow velocity to early diastolic mitral annular velocity did not differ between the groups. However, paricalcitol treatment significantly reduced intact parathyroid hormone (P<0.001) and alkaline phosphatase (P=0.001) levels as well as the number of cardiovascular-related hospitalizations compared with placebo. In conclusion, 52 weeks of treatment with oral paricalcitol (1 μg one time daily) significantly improved secondary hyperparathyroidism but did not alter measures of LV structure and function in patients with severe CKD.
Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong;
Angela Yee-Moon
AY
Wang
Fang
F
Fang
John
J
Chan
Yue-Yi
YY
Wen
Shang
S
Qing
Iris Hiu-Shuen
IH
Chan
Gladys
G
Lo
Kar-Neng
KN
Lai
Wai-Kei
WK
Lo
Christopher Wai-Kei
CW
Lam
Cheuk-Man
CM
Yu
D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D004452:Echocardiography; D004872:Ergocalciferols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006934:Hypercalcemia / Q000139:chemically induced; D017379:Hypertrophy, Left Ventricular / Q000188:drug therapy* / Q000209:etiology* / Q000473:pathology; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000188:drug therapy* / Q000473:pathology; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology
D004872:Ergocalciferols; C470125:PTH protein, human; D010281:Parathyroid Hormone; C084656:paricalcitol; D000469:Alkaline Phosphatase