Antonio Cittadini1, Alberto M Marra2, Michele Arcopinto2, Emanuele Bobbio2, Andrea Salzano2, Domenico Sirico2, Raffaele Napoli2, Annamaria Colao3, Salvatore Longobardi4, Ragavendra R Baliga5, Eduardo Bossone6, Luigi Saccà2. 1. Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy. Electronic address: antonio.cittadini@unina.it. 2. Department of Internal Medicine, Cardiovascular and Immunological Sciences, University "Federico II," Naples, Italy. 3. Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II," Naples, Italy. 4. Medical Liaison Office, Merck Serono S.p.A., Rome, Italy. 5. Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. 6. Cardiology Division, Cava dei Tirreni-Amalfi Coast Hospital, Heart Department, University of Salerno, Salerno, Italy.
Abstract
OBJECTIVES: 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.
RCT Entities:
OBJECTIVES: This study sought to evaluate the efficacy and safety of long-term growth hormone (GH) replacement therapy in GH-deficientpatients 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 CHFpatients (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.
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Authors: Michele Arcopinto; Andrea Salzano; Francesco Giallauria; Eduardo Bossone; Jörgen Isgaard; Alberto M Marra; Emanuele Bobbio; Olga Vriz; David N Åberg; Daniele Masarone; Amato De Paulis; Lavinia Saldamarco; Carlo Vigorito; Pietro Formisano; Massimo Niola; Francesco Perticone; Domenico Bonaduce; Luigi Saccà; Annamaria Colao; Antonio Cittadini Journal: PLoS One Date: 2017-01-17 Impact factor: 3.240
Authors: Aline R R Lima; Luana U Pagan; Ricardo L Damatto; Marcelo D M Cezar; Camila Bonomo; Mariana J Gomes; Paula F Martinez; Daniele M Guizoni; Dijon H S Campos; Felipe C Damatto; Katashi Okoshi; Marina P Okoshi Journal: Oncotarget Date: 2017-08-24