TY - JOUR
T1 - Randomised, double-blind, placebo-controlled trial of human recombinant growth hormone in patients with chronic heart failure due to dilated cardiomyopathy
AU - Osterziel, Karl Josef
AU - Strohm, Oliver
AU - Schuler, Jochen
AU - Friedrich, Matthias
AU - Hänlein, Dankward
AU - Willenbrock, Roland
AU - Anker, Stefan D.
AU - Poole-Wilson, Philip A.
AU - Ranke, Michael B.
AU - Dietz, Rainer
PY - 1998/4/25
Y1 - 1998/4/25
N2 - Background. Some studies have suggested that treatment with recombinant human growth increases left-ventricular mass haemodynamic and functional status in patients with heart failure due to dilated cardiomyopathy. We did a double-blind, randomised, placebo-controlled study of rhGH in patients with chronic heart failure due to dilated cardiomyopathy. Methods. 50 patients (43 men) were randomly allocated treatment with subcutaneous rhGH (2 IU daily) or placebo for a minimum of 12 weeks. The primary endpoints were the effects on left-ventricular mass and systolic wall stress. The secondary endpoints were the effects on left-ventricular size and function. Data were analysed by intention to treat. Findings. Patients in the rhGH group had an increase in left-ventricular mass compared with those in the placebo group (27%, p = 0.0001). There was no significant difference in left-ventricular systolic wall stress, mean blood pressure, or systemic vascular resistance between the two groups. New York Heart Association functional class, left-ventricular ejection fraction, and distance on the 6 min walking test were unchanged. The change in serum insulin-like growth factor (IGF)-I concentrations (rhGH 77 ng/ml; placebo -19 ng/mL, GH vs placebo p = 0.0001) was significantly related to the change in left-ventricular mass (r = 0.55, p = 0.0001). One patient in the rhGH group was withdrawn at 6 weeks because of worsening heart failure. Interpretation. There is a significant increase in left-ventricular mass in patients with dilated cardiomyopathy given rhGH but this is not accompanied by an improvement in clinical status. Changes in left-ventricular mass are related to changes in serum IGF-I concentrations. Whether a longer treatment period would provide clinical benefits and decrease mortality is unknown.
AB - Background. Some studies have suggested that treatment with recombinant human growth increases left-ventricular mass haemodynamic and functional status in patients with heart failure due to dilated cardiomyopathy. We did a double-blind, randomised, placebo-controlled study of rhGH in patients with chronic heart failure due to dilated cardiomyopathy. Methods. 50 patients (43 men) were randomly allocated treatment with subcutaneous rhGH (2 IU daily) or placebo for a minimum of 12 weeks. The primary endpoints were the effects on left-ventricular mass and systolic wall stress. The secondary endpoints were the effects on left-ventricular size and function. Data were analysed by intention to treat. Findings. Patients in the rhGH group had an increase in left-ventricular mass compared with those in the placebo group (27%, p = 0.0001). There was no significant difference in left-ventricular systolic wall stress, mean blood pressure, or systemic vascular resistance between the two groups. New York Heart Association functional class, left-ventricular ejection fraction, and distance on the 6 min walking test were unchanged. The change in serum insulin-like growth factor (IGF)-I concentrations (rhGH 77 ng/ml; placebo -19 ng/mL, GH vs placebo p = 0.0001) was significantly related to the change in left-ventricular mass (r = 0.55, p = 0.0001). One patient in the rhGH group was withdrawn at 6 weeks because of worsening heart failure. Interpretation. There is a significant increase in left-ventricular mass in patients with dilated cardiomyopathy given rhGH but this is not accompanied by an improvement in clinical status. Changes in left-ventricular mass are related to changes in serum IGF-I concentrations. Whether a longer treatment period would provide clinical benefits and decrease mortality is unknown.
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U2 - 10.1016/S0140-6736(97)11329-0
DO - 10.1016/S0140-6736(97)11329-0
M3 - Article
C2 - 9643742
AN - SCOPUS:0032565361
VL - 351
SP - 1233
EP - 1237
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 9111
ER -