Levocarnitine Improves Cardiac Function in Hemodialysis Patients With Left Ventricular Hypertrophy: A Randomized Controlled Trial.
BACKGROUND
Levocarnitine deficiency in hemodialysis patients is common. Although the effect of levocarnitine therapy on uremic anemia has been studied in small trials, its effects on cardiac function remain unclear.


METHODS
Multicenter, prospective, open-label, parallel, randomized, controlled trial.


METHODS
Patients undergoing maintenance hemodialysis with carnitine deficiency (free carnitine plasma concentration < 40μmol/L) enrolled in 3 hemodialysis centers.


METHODS
Random assignment to treatment for 12 months with oral levocarnitine therapy at a dose of 20mg/kg/d or control group (no levocarnitine therapy).


METHODS
Cardiac function was assessed by echocardiography. The primary end point was change in ejection fraction from baseline at the end of the study. Secondary end points included changes in left ventricular mass index and clinical parameters from baseline at the end of the study.


RESULTS
222 patients were randomly assigned, of whom 148 patients (levocarnitine group, n=75; control group, n=73) were analyzed. Ejection fraction increased from baseline to the end of the study in the levocarnitine group by 5.43% (95% CI, 4.53%-6.32%), but not in the control group (change, -0.14%; between-group difference, 5.57% [95% CI, 4.48%-6.66%]; P<0.001). Left ventricular mass index decreased from baseline to the end of the study in the levocarnitine group (change of -8.89 [95% CI, -11.7 to -6.09] g/m(2)), but not in the control group (change of 1.62g/m(2); between-group difference, 10.50 [95% CI, 7.51 to 13.60] g/m(2); P<0.001). Levocarnitine therapy reduced N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and improved the erythropoietin responsiveness index, whereas no such effects were observed in the control group.


CONCLUSIONS
Not a double-blinded study.


CONCLUSIONS
Levocarnitine therapy is useful for hemodialysis patients with carnitine deficiency; these patients may benefit from such therapy, with amelioration of cardiac function and reduction of left ventricular mass index.
Department of Nephrology, Keiai Hospital, Tokyo, Japan.
Terumi
T
Higuchi
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: abe.masanori@nihon-u.ac.jp.
Masanori
M
Abe
Department of Nephrology, Keiai Hospital, Tokyo, Japan.
Toshio
T
Yamazaki
Department of Nephrology, Keiai Hospital, Tokyo, Japan.
Erina
E
Okawa
Department of Cardiology, Keiai Hospital, Tokyo, Japan.
Hideyuki
H
Ando
Department of Clinical Laboratory, Keiai Hospital, Tokyo, Japan.
Sunao
S
Hotta
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.
Osamu
O
Oikawa
Department of Nephrology, Meirikai Chuo General Hospital, Tokyo, Japan.
Fumito
F
Kikuchi
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.
Kazuyoshi
K
Okada
Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.
Masayoshi
M
Soma
D000368:Aged; D000369:Aged, 80 and over; D002331:Carnitine / Q000097:blood / Q000172:deficiency / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000097:blood* / Q000175:diagnosis / Q000628:therapy*; D007676:Kidney Failure, Chronic / Q000097:blood* / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods / Q000639:trends*
D002331:Carnitine
Carnitine; N-terminal pro–brain natriuretic peptide (NT-proBNP); cardiac function; cardiac morphology; ejection fraction (EF); end-stage renal disease (ESRD); hemodialysis (HD); left ventricular hypertrophy (LVH); left ventricular mass index (LVMI); levocarnitine; randomized controlled trial (RCT)