1. Multiple hormonal and metabolic deficiency syndrome in chronic heart failure: rationale, design, and demographic characteristics of the T.O.S.CA. Registry
- Author
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Bossone, E., Arcopinto, M., Iacoviello, M., Triggiani, V., Cacciatore, F., Maiello, C., Limongelli, G., Masarone, D., Perticone, F., Sciacqua, A., Perrone-Filardi, P., Mancini, A., Volterrani, M., Vriz, O., Castello, R., Passantino, A., Campo, M., Modesti, P. A., de Giorgi, A., Monte, I., Puzzo, A., Ballotta, A., Caliendo, L., D’Assante, R., Marra, A. M., Salzano, A., Suzuki, T., Cittadini, A., Saccà, L., Monti, M. G., Napoli, R., Matarazzo, M., Stagnaro, F. M., Schiavo, A., Valente, P., Ferrara, F., Russo, V., Malinconico, M., Citro, R., Guastalamacchia, E., Leone, M., Amarelli, C., Mattucci, I., Calabrò, P., Calabrò, R., D’Andrea, A., Maddaloni, V., Pacileo, G., Scarafile, R., Belfiore, A., Cimellaro, A., Perrone Filardi, P., Casaretti, L., Paolillo, S., Gargiulo, P., Favuzzi, A. M. R., Di Segni, C., Bruno, C., Vergani, E., Massaro, R., Grimaldi, F., Frigo, A., Sorrentino, M. R., Malandrino, D., Manfredini, R., Fabbian, F., Ragusa, L., Carbone, L., Frigiola, A., Generali, T., Giacomazzi, F., de Vincentiis, C., Garofalo, P., Malizia, G., Milano, S., Misiano, G., Heaney, L. M., Bruzzese, D., Bossone E., Arcopinto M., Iacoviello M., Triggiani V., Cacciatore F., Maiello C., Limongelli G., Masarone D., Perticone F., Sciacqua A., Perrone-Filardi P., Mancini A., Volterrani M., Vriz O., Castello R., Passantino A., Campo M., Modesti P.A., De Giorgi A., Monte I., Puzzo A., Ballotta A., Caliendo L., D'Assante R., Marra A.M., Salzano A., Suzuki T., Cittadini A., Sacca L., Monti M.G., Napoli R., Matarazzo M., Stagnaro F.M., Schiavo A., Valente P., Ferrara F., Russo V., Malinconico M., Citro R., Guastalamacchia E., Leone M., Amarelli C., Mattucci I., Calabro P., Calabro R., D'Andrea A., Maddaloni V., Pacileo G., Scarafile R., Belfiore A., Cimellaro A., Casaretti L., Paolillo S., Gargiulo P., Favuzzi A.M.R., DiSegni C., Bruno C., Vergani E., Massaro R., Grimaldi F., Frigo A., Sorrentino M.R., Malandrino D., Manfredini R., DeGiorgi A., Fabbian F., Ragusa L., Carbone L., Frigiola A., Generali T., Giacomazzi F., DeVincentiis C., Garofalo P., Malizia G., Milano S., Misiano G., Heaney L.M., Bruzzese D., Bossone, E, Arcopinto, M, Iacoviello, M, Triggiani, V, Cacciatore, F, Maiello, C, Limongelli, G, Masarone, D, Perticone, F, Sciacqua, A, Perrone-Filardi, P, Mancini, A, Volterrani, M, Vriz, O, Castello, R, Passantino, A, Campo, M, A Modesti, P, De Giorgi, A, Monte, I, Puzzo, A, Ballotta, A, Caliendo, L, D'Assante, R, M Marra, A, Salzano, A, Suzuki, T, Cittadini, A, Investigators, Tosca, Bossone, E., Arcopinto, M., Iacoviello, M., Triggiani, V., Cacciatore, F., Maiello, C., Limongelli, G., Masarone, D., Perticone, F., Sciacqua, A., Perrone-Filardi, P., Mancini, A., Volterrani, M., Vriz, O., Castello, R., Passantino, A., Campo, M., Modesti, P. A., de Giorgi, A., Monte, I., Puzzo, A., Ballotta, A., Caliendo, L., D’Assante, R., Marra, A. M., Salzano, A., Suzuki, T., Cittadini, A., Saccà, L., Monti, M. G., Napoli, R., Matarazzo, M., Stagnaro, F. M., Schiavo, A., Valente, P., Ferrara, F., Russo, V., Malinconico, M., Citro, R., Guastalamacchia, E., Leone, M., Amarelli, C., Mattucci, I., Calabrò, P., Calabrò, R., D’Andrea, A., Maddaloni, V., Pacileo, G., Scarafile, R., Belfiore, A., Cimellaro, A., Perrone Filardi, P., Casaretti, L., Paolillo, S., Gargiulo, P., Favuzzi, A. M. R., Di Segni, C., Bruno, C., Vergani, E., Massaro, R., Grimaldi, F., Frigo, A., Sorrentino, M. R., Malandrino, D., Manfredini, R., Fabbian, F., Ragusa, L., Carbone, L., Frigiola, A., Generali, T., Giacomazzi, F., de Vincentiis, C., Garofalo, P., Malizia, G., Milano, S., Misiano, G., Heaney, L. M., and Bruzzese, D.
- Subjects
Male ,Anabolism ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Clinical endpoint ,Medicine ,Deficiency Disease ,030212 general & internal medicine ,Prospective Studies ,Registries ,Prospective cohort study ,Testosterone ,Anabolic deficiency ,Chronic heart failure ,Heart failure metabolism ,Multiple hormonal deficiency syndrome ,Registry ,Aged ,Biomarkers ,Chronic Disease ,Deficiency Diseases ,Disease Progression ,Female ,Heart Failure ,Humans ,Italy ,Metabolic Diseases ,Middle Aged ,Internal Medicine ,Emergency Medicine ,Human ,medicine.medical_specialty ,Anabolic deficiency, Chronic heart failure, Heart failure metabolism, Multiple hormonal deficiency syndrome, Registry ,Socio-culturale ,03 medical and health sciences ,Internal medicine ,business.industry ,Settore MED/13 - ENDOCRINOLOGIA ,Biomarker ,medicine.disease ,Metabolic Disease ,Prospective Studie ,Heart failure ,Observational study ,Hormone therapy ,business - Abstract
Recent evidence supports the concept that progression of chronic heart failure (CHF) depends upon an imbalance of catabolic forces over the anabolic drive. In this regard, multiple hormonal deficiency syndrome (MHDS) significantly has impacts upon CHF progression, and is associated with a worse clinical status and increased mortality. The T.O.S.CA. (Trattamento Ormonale nello Scompenso CArdiaco; Hormone Therapy in Heart Failure) Registry (clinicaltrial.gov = NCT02335801) tests the hypothesis that anabolic deficiencies reduce survival in a large population of mild-to-moderate CHF patients. The T.O.S.CA. Registry is a prospective multicenter observational study coordinated by “Federico II” University of Naples, and involves 19 centers situated throughout Italy. Thyroid hormones, insulin-like growth factor-1, total testosterone, dehydroepiandrosterone , and insulin are measured at baseline and every year for a patient-average follow-up of 3years. Subjects with CHF are divided into two groups: patients with one or no anabolic deficiency, and patients with two or more anabolic deficiencies at baseline. The primary endpoint is the composite of all-cause mortality and cardiovascular hospitalization. Secondary endpoints include the composite of all-cause mortality and hospitalization, the composite of cardiovascular mortality and cardiovascular hospitalization, and change of VO 2 peak. Patient enrollment started in April 2013, and was completed in July 2017. Demographics and main clinical characteristics of enrolled patients are provided in this article. Detailed cross-sectional results will be available in late 2018. The T.O.S.CA. Registry represents the most robust prospective observational trial on MHDS in the field of CHF. The study findings will advance our knowledge with regard to the intimate mechanisms of CHF progression and hopefully pave the way for future randomized clinical trials of single or multiple hormonal replacement therapies in CHF.
- Published
- 2017