RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF HUMAN RECOMBINANT GROWTH-HORMONE IN PATIENTS WITH CHRONIC HEART-FAILURE DUE TO DILATED CARDIOMYOPATHY

Background Some studies have suggested that treatment with recombinant human growth hormone (rhGH) increases left-ventricular mass and impro ves haemodynamic and functional status in patients with heart failure due to dilated cardiomyopathy. We did a double-blind, randomised, plac ebo-controlled study of rhGH in patients with chronic heart failure du e to dilated cardiomyopathy. Methods 50 patients (43 men) were randoml y allocated treatment with subcutaneous rhGH (2 IU daily) or placebo f or a minimum of 12 weeks. The primary endpoints were the effects on le ft-ventricular mass and systolic wall stress. The secondary endpoints were the effects on left-ventricular size and function. Data were anal ysed 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-ven tricular systolic wall stress, mean blood pressure, or systemic vascul ar resistance between the two groups. New York Heart Association funct ional class, left-ventricular ejection fraction, and distance on the 6 min walking test were unchanged. The change in serum insulin-like gro wth factor (IGF)-I concentrations (rhGH 77 ng/mL; placebo -19 ng/mL, G H 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 One patient in the rhGH group wa s withdrawn at 6 weeks because of worsening heart failure. Interpretat ion There is a significant increase in left-ventricular mass in patien ts 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 longe r treatment period would provide clinical benefits and decrease mortal ity is unknown.