title: Growth hormone replacement delays the progression of chronic heart failure combined with growth hormone deficiency: an extension of a randomized controlled single-blind study.
abstract: OBJECTIVE
  This study sought to evaluate the efficacy and safety of long-term growth hormone (GH) replacement therapy in GH-deficient patients with chronic heart failure (CHF).
  
  
  BACKGROUND
  Recent evidence indicates that growth hormone deficiency (GHD) affects as many as 40% of patients with CHF, and short-term GH replacement causes functional benefit. Whether long-term GH replacement also affects CHF progression is unknown.
  
  
  METHODS
  The study is an extension of a previous randomized, controlled single-blind trial that screened 158 consecutive CHF patients (New York Heart Association classes II to IV) and identified 63 who had GHD by the growth hormone releasing hormone plus arginine test. Fifty-six patients were randomized to receive either GH therapy or standard CHF therapy. Patients were evaluated at baseline and after a 4-year follow-up. The primary endpoint was peak oxygen consumption (VO2). Secondary endpoints included left ventricular (LV) ejection fraction and volumes, serum amino terminal fragment of the pro-hormone brain-type natriuretic peptide, quality of life, and safety.
  
  
  RESULTS
  Seventeen patients in the GH group and 14 in the control group completed the study. In the GH group, peak VO2 improved over the 4-year follow-up. The treatment effect was 7.1 ± 0.7 ml/kg/min versus -1.8 ± 0.5 ml/kg/min in the GH and control groups, respectively. At 4 years, LV ejection fraction increased by 10 ± 3% in the GH group, whereas it decreased by 2 ± 5% in control patients. The treatment effect on LV end-systolic volume index was -22 ± 6 ml and 8 ± 3 ml/m(2) in the GH and control groups, respectively (all p < 0.001). No major adverse events were reported in the patients who received GH.
  
  
  CONCLUSIONS
  Although this is a preliminary study, the finding suggests a new therapeutic approach to a large proportion of GHD patients with CHF.
authors.affiliation: Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy. Electronic address: antonio.cittadini@unina.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Cittadini
authors.affiliation: Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy.
authors.forename: Alberto M
authors.initials: AM
authors.lastname: Marra
authors.affiliation: Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Arcopinto
authors.affiliation: Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Bobbio
authors.affiliation: Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Salzano
authors.affiliation: Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Sirico
authors.affiliation: Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Napoli
authors.affiliation: Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II," Naples, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Colao
authors.affiliation: Medical Liaison Office, Merck Serono S.p.A., Rome, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Longobardi
authors.affiliation: Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.
authors.forename: Ragavendra R
authors.initials: RR
authors.lastname: Baliga
authors.affiliation: Cardiology Division, Cava dei Tirreni-Amalfi Coast Hospital, Heart Department, University of Salerno, Salerno, Italy.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bossone
authors.affiliation: Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Saccà
mesh_terms: D002908:Chronic Disease; D003677:Deficiency Diseases / Q000150:complications / Q000188:drug therapy; D018450:Disease Progression; D005260:Female; D013006:Growth Hormone / Q000627:therapeutic use*; D006333:Heart Failure / Q000150:complications* / Q000188:drug therapy*; D020249:Hormone Replacement Therapy; D019382:Human Growth Hormone / Q000172:deficiency*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method
chemical_list: D019382:Human Growth Hormone; D013006:Growth Hormone
keywords: GH replacement; chronic heart failure; longterm