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1. Epigenetic Therapies for Heart Failure: Current Insights and Future Potential

Author

Napoli C, Bontempo P, Palmieri V, Coscioni E, Maiello C, Donatelli F, and Benincasa G

Subjects
heart failure, personalized therapy, epidrugs., Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Claudio Napoli,1 Paola Bontempo,2 Vittorio Palmieri,3 Enrico Coscioni,4 Ciro Maiello,5 Francesco Donatelli,6 Giuditta Benincasa1 1Department of Advanced Medical and Surgical Sciences (DAMSS), University of Campania “Luigi Vanvitelli”, Naples, 80138, Italy; 2Department of Precision Medicine, University of Campania “Luigi Vanvitelli”, Naples, 80138, Italy; 3Department of Cardiac Surgery and Transplantation, Heart Transplantation Unit in Adults of the ‘Ospedali dei Colli Monaldi-Cotugno-CTO’, Naples, Italy; 4Department of Cardiac Surgery, Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d’Aragona, Salerno, Italy; 5Department of Cardiovascular Surgery and Transplants, Monaldi Hospital, Azienda dei Colli, Naples, Italy; 6Chair of Cardiac Surgery, Department of Cardiothoracic Center, Istituto Clinico Sant’Ambrogio, University of Milan, Milan, ItalyCorrespondence: Giuditta BenincasaDepartment of Advanced Medical and Surgical Sciences (DAMSS), University of Campania “Luigi Vanvitelli”, Naples, ItalyTel +390815667916Email giuditta.benincasa@unicampania.itAbstract: Despite the current reductionist approach providing an optimal indication for diagnosis and treatment of patients with heart failure with reduced ejection fraction (HFrEF), there are no standard pharmacological therapies for heart failure with preserved ejection fraction (HFpEF). Although in its infancy in cardiovascular diseases, the epigenetic-based therapy (“epidrugs”) is capturing the interest of physician community. In fact, an increasing number of controlled clinical trials is evaluating the putative beneficial effects of: 1) direct epigenetic-oriented drugs, eg, apabetalone, and 2) repurposed drugs with a possible indirect epigenetic interference, eg, metformin, statins, sodium glucose transporter inhibitors 2 (SGLT2i), and omega 3 polyunsaturated fatty acids (PUFAs) in both HFrEF and HFpEF, separately. Apabetalone is the first and unique direct epidrug tested in cardiovascular patients to date, and the BETonMACE trial has reported a reduction in first HF hospitalization (any EF value) and cardiovascular death in patients with type 2 diabetes and recent acute coronary syndrome, suggesting a possible role in secondary prevention. Patients with HFpEF seem to benefit from supplementation to the standard therapy with statins, metformin, and SGLT2i owing to their ability in reducing mortality. In contrast, the vasodilator hydralazine, with or without isosorbide dinitrate, did not provide beneficial effects. In HFrEF, metformin and SGLT2i could reduce the risk of incident HF and mortality in affected patients whereas clinical trials based on statins provided mixed results. Furthermore, PUFAs diet supplementation was significantly associated with reduced cardiovascular risk in both HFpEF and HFrEF. Future large trials will reveal whether direct and indirect epitherapy will remain a work in progress or become a useful way to customize the therapy in the real-world management of HFpEF and HFrEF. Our goal is to discuss the recent advancement in the epitherapy as a possible way to improve personalized therapy of HF.Keywords: heart failure, personalized therapy, epidrugs

Published
2021

3. Multiple hormonal and metabolic deficiency syndrome in chronic heart failure: rationale, design, and demographic characteristics of the T.O.S.CA. Registry

Author

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., and On behalf of TOSCA Investigators

Published
2018
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5. Progressive right ventricular dysfunction and exercise impairment in patients with heart failure and diabetes mellitus: insights from the T.O.S.CA. Registry

Author

Salzano, A, D'Assante, R, Iacoviello, M, Triggiani, V, Rengo, G, Cacciatore, F, Maiello, C, Limongelli, G, Masarone, D, Sciacqua, A, Perrone Filardi, P, Mancini, A, Volterrani, M, Vriz, O, Castello, R, Passantino, A, Campo, M, Modesti, Pa, De Giorgi, A, Arcopinto, M, Gargiulo, P, Perticone, M, Colao, A, Milano, S, Garavaglia, A, Napoli, R, Suzuki, T, Bossone, E, Marra, Am, Cittadini, A, Saccà, L, Monti, Mg, Matarazzo, M, Stagnaro, Fm, Piccioli, L, Lombardi, A, Panicara, V, Flora, M, Golia, L, Faga, V, Ruocco, A, Della Polla, D, Franco, R, Schiavo, A, Gigante, A, Spina, E, Sicuranza, M, Monaco, F, Apicella, M, Miele, C, Campanino, Ag, Mazza, L, Abete, R, Farro, A, Luciano, F, Polizzi, R, Ferrillo, G, De Luca, M, Crisci, G, Giardino, F, Barbato, M, Ranieri, B, Ferrara, F, Russo, V, Malinconico, M, Citro, R, Guastalamacchia, E, Leone, M, Giagulli, Va, Amarelli, C, Mattucci, I, Calabrò, P, Calabrò, R, D'Andrea, A, Maddaloni, V, Pacileo, G, Scarafile, R, Belfiore, A, Cimellaro, A, Casaretti, L, Paolillo, S, Favuzzi, Amr, Di Segni, C, Bruno, C, Vergani, E, Massaro, R, Grimaldi, F, Frigo, A, Sorrentino, Mr, Malandrino, D, Manfredini, R, Fabbian, F, Puzzo, A, Ragusa, L, Caliendo, L, Carbone, L, Frigiola, A, Generali, T, Giacomazzi, F, De Vincentiis, C, Ballotta, A, Garofalo, P, Malizia, G, Misiano, G, Israr, Mz, Bernieh, D, Cassambai, S, Yazaki, Y, Heaney, Lm, Eagle, Ka, Ventura, Ho, Bruzzese, D, Salzano, Andrea, D'Assante, Roberta, Iacoviello, Massimo, Triggiani, Vincenzo, Rengo, Giuseppe, Cacciatore, Francesco, Maiello, Ciro, Limongelli, Giuseppe, Masarone, Daniele, Sciacqua, Angela, Filardi, Pasquale Perrone, Mancini, Antonio, Volterrani, Maurizio, Vriz, Olga, Castello, Roberto, Passantino, Andrea, Campo, Michela, Modesti, Pietro A, De Giorgi, Alfredo, Arcopinto, Michele, Gargiulo, Paola, Perticone, Maria, Colao, Annamaria, Milano, Salvatore, Garavaglia, Agnese, Napoli, Raffaele, Suzuki, Toru, Bossone, Eduardo, Marra, Alberto M, Cittadini, Antonio, and Misiano, Gabriella

Subjects
Registrie, Heart Failure, Endocrinology, Diabetes and Metabolism, Ventricular Dysfunction, Right, Diabetes, Insulins, Socio-culturale, Stroke Volume, Insulin resistance, Diabete, Cardiopulmonary exercise test, Chronic heart failure, Diabetes, Insulin resistance, Right ventricle, TOSCA Registry, Chronic heart failure, Diabetes Mellitus, Type 2, TOSCA Registry, Exercise Test, Ventricular Function, Right, Humans, Insulin, Right ventricle, Registries, Cardiology and Cardiovascular Medicine, Cardiopulmonary exercise test, TOSCA, Human, LS4_7
Abstract

Background Findings from the T.O.S.CA. Registry recently reported that patients with concomitant chronic heart failure (CHF) and impairment of insulin axis (either insulin resistance—IR or diabetes mellitus—T2D) display increased morbidity and mortality. However, little information is available on the relative impact of IR and T2D on cardiac structure and function, cardiopulmonary performance, and their longitudinal changes in CHF. Methods Patients enrolled in the T.O.S.CA. Registry performed echocardiography and cardiopulmonary exercise test at baseline and at a patient-average follow-up of 36 months. Patients were divided into three groups based on the degree of insulin impairment: euglycemic without IR (EU), euglycemic with IR (IR), and T2D. Results Compared with EU and IR, T2D was associated with increased filling pressures (E/e′ratio: 15.9 ± 8.9, 12.0 ± 6.5, and 14.5 ± 8.1 respectively, p 2) in TD2 vs EU and IR patients was recorded (respectively, 15.8 ± 3.8 ml/Kg/min, 18.4 ± 4.3 ml/Kg/min and 16.5 ± 4.3 ml/Kg/min, p 2 in the T2D group (+ 13% increase in RV dimension, − 21% decline in TAPSE/PAPS ratio and − 20% decrease in peak VO2). Conclusion The higher risk of death and CV hospitalizations exhibited by HF-T2D patients in the T.O.S.CA. Registry is associated with progressive RV ventricular dysfunction and exercise impairment when compared to euglycemic CHF patients, supporting the pivotal importance of hyperglycaemia and right chambers in HF prognosis. Trial registration ClinicalTrials.gov identifier: NCT023358017

Published
2022
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9. Multiple hormonal and metabolic deficiency syndrome predicts outcome in heart failure: the T.O.S.CA. Registry

Author

Cittadini A., Salzano A., Iacoviello M., Triggiani V., Rengo G., Cacciatore F., Maiello C., Limongelli G., Masarone D., Perticone F., Cimellaro A., Filardi P. P., Paolillo S., Mancini A., Volterrani M., Vriz O., Castello R., Passantino A., Campo M., Modesti P. A., de Giorgi A., Monte I. P., Puzzo A., Ballotta A., D'Assante R., Arcopinto M., Gargiulo P., Sciacqua A., Bruzzese D., Colao A., Napoli R., Suzuki T., Eagle K. A., Ventura H. O., Marra A. M., Bossone E., Sacca L., Monti M. G., Matarazzo M., Stagnaro F. M., Piccioli L., Lombardi A., Panicara V., Flora M., Golia L., Faga V., Ruocco A., della Polla D., Franco R., Schiavo A., Gigante A., Spina E., Sicuranza M., Monaco F., Apicella M., Miele C., Campanino A. G., Mazza L., Abete R., Farro A., Luciano F., Polizzi R., Ferrillo G., de Luca M., Crisci G., Giardino F., Barbato M., Ranieri B., Ferrara F., Russo V., Malinconico M., Citro R., Guastalamacchia E., Leone M., Giagulli V. A., Amarelli C., Mattucci I., Calabro P., Calabro R., D'Andrea A., Maddaloni V., Pacileo G., Scarafile R., Belfiore A., Casaretti L., Favuzzi A. M. R., Di Segni C., Bruno C., Vergani E., Massaro R., Grimaldi F., Frigo A., Campo M. R., Sorrentino M. R., Malandrino D., Manfredini R., Fabbian F., Ragusa L., Caliendo L., Carbone L., Frigiola A., Generali T., Giacomazzi F., de Vincentiis C., Garofalo P., Malizia G., Milano S., Misiano G., Israr M. Z., Bernieh D., Cassambai S., Yazaki Y., Heaney L. M., Cittadini, Antonio, Salzano, Andrea, Iacoviello, Massimo, Triggiani, Vincenzo, Rengo, Giuseppe, Cacciatore, Francesco, Maiello, Ciro, Limongelli, Giuseppe, Masarone, Daniele, Perticone, Francesco, Cimellaro, Antonio, Perrone Filardi, Pasquale, Paolillo, Stefania, Mancini, Antonio, Volterrani, Maurizio, Vriz, Olga, Castello, Roberto, Passantino, Andrea, Campo, Michela, Modesti, Pietro A, De Giorgi, Alfredo, Monte, Ines P, Puzzo, Alfonso, Ballotta, Andrea, D'Assante, Roberta, Arcopinto, Michele, Gargiulo, Paola, Sciacqua, Angela, Bruzzese, Dario, Colao, Annamaria, Napoli, Raffaele, Suzuki, Toru, Eagle, Kim A, Ventura, Hector O, Marra, Alberto M, Bossone, Eduardo, Cittadini, A., Salzano, A., Iacoviello, M., Triggiani, V., Rengo, G., Cacciatore, F., Maiello, C., Limongelli, G., Masarone, D., Perticone, F., Cimellaro, A., Filardi, P. P., Paolillo, S., Mancini, A., Volterrani, M., Vriz, O., Castello, R., Passantino, A., Campo, M., Modesti, P. A., de Giorgi, A., Monte, I. P., Puzzo, A., Ballotta, A., D'Assante, R., Arcopinto, M., Gargiulo, P., Sciacqua, A., Bruzzese, D., Colao, A., Napoli, R., Suzuki, T., Eagle, K. A., Ventura, H. O., Marra, A. M., Bossone, E., Sacca, L., Monti, M. G., Matarazzo, M., Stagnaro, F. M., Piccioli, L., Lombardi, A., Panicara, V., Flora, M., Golia, L., Faga, V., Ruocco, A., della Polla, D., Franco, R., Schiavo, A., Gigante, A., Spina, E., Sicuranza, M., Monaco, F., Apicella, M., Miele, C., Campanino, A. G., Mazza, L., Abete, R., Farro, A., Luciano, F., Polizzi, R., Ferrillo, G., de Luca, M., Crisci, G., Giardino, F., Barbato, M., Ranieri, B., Ferrara, F., Russo, V., Malinconico, M., Citro, R., Guastalamacchia, E., Leone, M., Giagulli, V. A., Amarelli, C., Mattucci, I., Calabro, P., Calabro, R., D'Andrea, A., Maddaloni, V., Pacileo, G., Scarafile, R., Belfiore, A., Casaretti, L., Favuzzi, A. M. R., Di Segni, C., Bruno, C., Vergani, E., Massaro, R., Grimaldi, F., Frigo, A., Campo, M. R., Sorrentino, M. R., Malandrino, D., Manfredini, R., Fabbian, F., Ragusa, L., Caliendo, L., Carbone, L., Frigiola, A., Generali, T., Giacomazzi, F., de Vincentiis, C., Garofalo, P., Malizia, G., Milano, S., Misiano, G., Israr, M. Z., Bernieh, D., Cassambai, S., Yazaki, Y., and Heaney, L. M.

Subjects
medicine.medical_specialty, Multiple hormonal and metabolic deficiency syndrome, Epidemiology, Prognosi, Anabolic deficiency, Socio-culturale, Heart failure, 030204 cardiovascular system & hematology, Ventricular Function, Left, 03 medical and health sciences, 0302 clinical medicine, Insulin resistance, Diabetes mellitus, Internal medicine, Multiple hormonal, medicine, Clinical endpoint, Humans, 030212 general & internal medicine, Prospective Studies, Registries, TOSCA, LS4_7, Ejection fraction, business.industry, Hazard ratio, Metabolic deficiency syndrome, Heart failure • Anabolic deficiency • Multiple hormonal and metabolic deficiency syndrome • Hormones • Prognosis • TOSCA, Stroke Volume, medicine.disease, Prognosis, Hormone, Confidence interval, Heart failure, Anabolic deficiency, Multiple hormonal and metabolic deficiency syndrome, Hormones, Prognosis, TOSCA, Hormones, Hospitalization, Observational study, Cardiology and Cardiovascular Medicine, business
Abstract

Aims Recent evidence supports the occurrence of multiple hormonal and metabolic deficiency syndrome (MHDS) in chronic heart failure (CHF). However, no large observational study has unequivocally demonstrated its impact on CHF progression and outcome. The T.O.S.CA. (Trattamento Ormonale nello Scompenso CArdiaco; Hormone Treatment in Heart Failure) Registry has been specifically designed to test the hypothesis that MHDS affects morbidity and mortality in CHF patients. Methods and Results The T.O.S.CA. Registry is a prospective, multicentre, observational study involving 19 Italian centres. Thyroid hormones, insulin-like growth factor-1, total testosterone, dehydropianoandrosterone sulfate, insulin resistance, and the presence of diabetes were evaluated. A MHDS was defined as the presence of ≥2 hormone deficiencies (HDs). Primary endpoint was a composite of all-cause mortality and cardiovascular hospitalizations. Four hundred and eighty heart failure patients with ejection fraction ≤45% were enrolled. MHDS or diabetes was diagnosed in 372 patients (77.5%). A total of 271 events (97 deaths and 174 cardiovascular hospitalizations) were recorded, 41% in NO-MHDS and 62% in MHDS (P Conclusion MHDS is common in CHF and independently associated with increased all-cause mortality and cardiovascular hospitalization, representing a promising therapeutic target. Trial registration ClinicalTrials.gov identifier: NCT023358017

Published
2021

13. Factors Influencing Access to Transplant, Waitlist Mortality, and Post-Transplant Survival in the Italian National Heart Transplant Database

Author

Frigerio, M, Varrenti, M, Santolamazza, C, Bernasconi, D, Costa, A, Oliveti, A, Puoti, F, Bottio, T, Gerosa, G, Russo, C, Giannattasio, C, Tursi, V, Livi, U, Maiello, C, Amarelli, C, Potena, L, Martin Suarez, S, Boffini, M, Pace Napoleone, C, Clemenza, F, Musumeci, F, Maccherini, M, Faggian, G, Pellegrini, C, Terzi, A, Tramontin, C, De Angelis, D, Milano, A, Valsecchi, M, Frigerio, M., Varrenti, M., Santolamazza, C., Bernasconi, D. P., Costa, A. Nanni, Oliveti, A., Puoti, F., Bottio, T., Gerosa, G., Russo, C. F., Giannattasio, C., Tursi, V., Livi, U., Maiello, C., Amarelli, C., Potena, L., Martin Suarez, S., Boffini, M., Pace Napoleone, C., Clemenza, F., Musumeci, F., Maccherini, M., Faggian, G., Pellegrini, C., Terzi, A., Tramontin, C., De Angelis, D., Milano, A. D., Valsecchi, M., Frigerio, M, Varrenti, M, Santolamazza, C, Bernasconi, D, Costa, A, Oliveti, A, Puoti, F, Bottio, T, Gerosa, G, Russo, C, Giannattasio, C, Tursi, V, Livi, U, Maiello, C, Amarelli, C, Potena, L, Martin Suarez, S, Boffini, M, Pace Napoleone, C, Clemenza, F, Musumeci, F, Maccherini, M, Faggian, G, Pellegrini, C, Terzi, A, Tramontin, C, De Angelis, D, Milano, A, Valsecchi, M, Frigerio, M., Varrenti, M., Santolamazza, C., Bernasconi, D. P., Costa, A. Nanni, Oliveti, A., Puoti, F., Bottio, T., Gerosa, G., Russo, C. F., Giannattasio, C., Tursi, V., Livi, U., Maiello, C., Amarelli, C., Potena, L., Martin Suarez, S., Boffini, M., Pace Napoleone, C., Clemenza, F., Musumeci, F., Maccherini, M., Faggian, G., Pellegrini, C., Terzi, A., Tramontin, C., De Angelis, D., Milano, A. D., and Valsecchi, M.

Published
2019

15. Multiple hormonal and metabolic deficiency syndrome in chronic heart failure: rationale, design, and demographic characteristics of the T.O.S.CA. Registry

Author

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

20. P4543Steatosis in explanted heart of type 2 diabetic patients with end-stage heart failure: progression of intra-myocytes fat accumulation in non-diabetic heart implanted in diabetic patients

Author

Marfella, R, primary, Cacciatore, F, additional, Balestrieri, M L, additional, Esposito, S, additional, Mansueto, G, additional, Paolisso, P, additional, Golino, P, additional, Amarelli, C, additional, Maiello, C, additional, Ursomando, F, additional, Salerno, G, additional, Palmieri, V, additional, Benincasa, G, additional, Paolisso, G, additional, and Napoli, C, additional

Published
2019
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21. Factors Influencing Access to Transplant, Waitlist Mortality, and Post-Transplant Survival in the Italian National Heart Transplant Database

Author

Frigerio, M., primary, Varrenti, M., additional, Santolamazza, C., additional, Bernasconi, D.P., additional, Costa, A. Nanni, additional, Oliveti, A., additional, Puoti, F., additional, Bottio, T., additional, Gerosa, G., additional, Russo, C.F., additional, Giannattasio, C., additional, Tursi, V., additional, Livi, U., additional, Maiello, C., additional, Amarelli, C., additional, Potena, L., additional, Martin Suarez, S., additional, Boffini, M., additional, Pace Napoleone, C., additional, Clemenza, F., additional, Musumeci, F., additional, Maccherini, M., additional, Faggian, G., additional, Pellegrini, C., additional, Terzi, A., additional, Tramontin, C., additional, De Angelis, D., additional, Milano, A.D., additional, and Valsecchi, M., additional

Published
2019
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22. Optimizing the Safety Profile of Everolimus by Delayed Initiation in De Novo Heart Transplant Recipients: Results of the Prospective Randomized Study EVERHEART

Author

Potena, L., Pellegrini, C., Grigioni, F., Amarelli, C., Livi, U., Maccherini, M., Masciocco, G., Faggian, G., Lilla Della Monica, P., Gerosa, G., Marraudino, N., Corda, M., Boffini, M., De Santo, L. S., Tona, F., Poggio, D., Savini, C., Ambrogi, F., Bernazzali, S., D'Armini, A. M., Mattiucci, G., Rinaldi, M., Ribezzo, M., Porcu, M., Musumeci, F., Gambino, A., Maiello, C., Frigerio, M., Guzzi, G., Forni, A., and Capone, G.

Subjects
Male, medicine.medical_specialty, Pleural effusion, medicine.medical_treatment, 030204 cardiovascular system & hematology, 030230 surgery, Pericardial effusion, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Cumulative incidence, Everolimus, Prospective Studies, Prospective cohort study, Heart transplantation, Transplantation, business.industry, Original Clinical Science—General, medicine.disease, Surgery, Discontinuation, Heart Transplantation, Female, Immunosuppressive Agents, business, medicine.drug
Abstract

Background Although everolimus potentially improves long-term heart transplantation (HTx) outcomes, its early postoperative safety profile had raised concerns and needs optimization. Methods This 6-month, open-label, multicenter randomized trial was designed to compare the cumulative incidence of a primary composite safety endpoint comprising wound healing delays, pericardial effusion, pleural effusion needing drainage, and renal insufficiency events (estimated glomerular filtration rate ≤30/mL/min per 1.73 m2) in de novo HTx recipients receiving immediate everolimus (EVR-I) (≤144 hours post-HTx) or delayed everolimus (EVR-D) (4-6 weeks post-HTx with mycophenolate mofetil as a bridge) with reduced-dose cyclosporine A. Cumulative incidence of biopsy-proven rejection ≥ 2R, rejection with hemodynamic compromise, graft loss, or death was the secondary composite efficacy endpoint. Results Overall, 181 patients were randomized to the EVR-I (n = 89) or EVR-D (n = 92) arms. Incidence of primary safety endpoint was higher for EVR-I than EVR-D arm (44.9% vs 32.6%; P = 0.191), mainly driven by a higher rate of pericardial effusion (33.7% vs 19.6%; P = 0.04); wound healing delays, acute renal insufficiency events, and pleural effusion occurred at similar frequencies in the study arms. Efficacy failure was not significantly different in EVR-I arm versus EVR-D arm (37.1% vs 28.3%; P = 0.191). Three patients in the EVR-I arm and 1 in the EVR-D arm died. Incidence of clinically significant adverse events leading to discontinuation was higher in EVR-I arm versus EVR-D arm (P = 0.02). Conclusions Compared with immediate initiation, delayed everolimus initiation appeared to provide a clinically relevant early safety benefit in de novo HTx recipients, without compromising efficacy., The 6-month, open-label, multicenter randomized trial is designed to compare primary safety endpoints in de novo heart transplantation and delayed everolimus initiation seems to provide a clinically relevant early safety benefit compared to immediate initiation without compromising efficacy. Supplemental digital content is available in the text.

Published
2018

23. Seroprevalence of Bartonella henselae in patients awaiting heart transplant in Southern Italy

Author

Picascia A, Pagliuca C, Colicchio R, CASAMASSIMI, Amelia, Labonia F, Pastore G, Pagliarulo C, Cicatiello AG, Castaldo F, Schiano C, Maiello C, Mezza E, D'Armiento FP, Salvatore P, Napoli C., SOMMESE, Linda, Picascia, A, Pagliuca, C, Sommese, Linda, Colicchio, R, Casamassimi, Amelia, Labonia, F, Pastore, G, Pagliarulo, C, Cicatiello, Ag, Castaldo, F, Schiano, C, Maiello, C, Mezza, E, D'Armiento, Fp, Salvatore, P, and Napoli, C.

Published
2015

24. Heart failure: Pilot transcriptomic analysis of cardiac tissue by RNA-sequencing

Author

Schiano C 1, Costa V 2, Aprile M 2, Grimaldi V 3, Maiello C 4, Esposito R 2, Soricelli A 1, 5, Colantuoni V 6, Donatelli F 7, Ciccodicola A 2, Napoli C 1, 3, Schiano, Concetta, Costa, Valerio, Aprile, Marianna, Grimaldi, Vincenzo, Maiello, Ciro, Esposito, Roberta, Soricelli, Andrea, Colantuoni, Vittorio, Donatelli, Francesco, Ciccodicola, Alfredo, and Napoli, Claudio

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, Pathology, Population, RNA-sequencing, Pilot Projects, Heart failure, NoncodingRNA, Disease, Bioinformatics, Ventricular Function, Left, Transcriptome, Ventricular Dysfunction, Left, 03 medical and health sciences, Internal medicine, medicine, Humans, Gene Regulatory Networks, RNA, Messenger, Mediator complex, Family history, education, Gene, Aged, education.field_of_study, Sequence Analysis, RNA, business.industry, Gene Expression Profiling, Myocardium, Cardiovascular disease, Cardiology and Cardiovascular Medicine, Restrictive cardiomyopathy, Computational Biology, Dilated cardiomyopathy, General Medicine, Middle Aged, medicine.disease, ncRNA, 030104 developmental biology, Case-Control Studies, Cardiology, Female, RNA, Long Noncoding, cardiovascular disease, heart failure, mediator complex, business
Abstract

Background: Despite left ventricular (LV) dysfunction contributing to mortality in chronic heart failure (HF), the molecular mechanisms of LV failure continues to remain poorly understood and myocardial biomarkers have yet to be identified. The aim of this pilot study was to investigate specific transcriptome changes occurring in cardiac tissues of patients with HF compared to healthy condition patients to improve diagnosis and possible treatment of affected subjects. Methods: Unlike other studies, only dilated cardiomyopathy (DCM) (n = 2) and restrictive cardiomyopathy (RCM) (n = 2) patients who did not report family history of the disease were selected with the aim of obtaining a homogeneous population for the study. The transcriptome of all patients were studied by RNA-sequencing (RNA-Seq) and the read counts were adequately filtered and normalized using a recently developed user-friendly tool for RNA-Seq data analysis, based on a new graphical user interface (RNA-SeqGUI). Results: By using this approach in a pairwise comparison with healthy donors, we were able to identify DCM- and RCM-specific expression signatures for protein-coding genes as well as for long noncoding RNAs (lncRNAs). Differential expression of 5 genes encoding different members of the mediator complex was disclosed in this analysis. Interestingly, a significant alteration was found for genes which had never been associated with HF until now, and 27 lncRNA/mRNA pairs that were significantly altered in HF patients. Conclusions: The present findings revealed specific expression pattern of both protein-coding and lncRNAs in HF patients, confirming that new LV myocardial biomarkers could be reliably identified using Next-Generation Sequencing-based approaches.

Published
2017
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26. GENE EXPRESSION ALTERATIONS IN HUMAN HEART FAILURE BY RNA-SEQUENCING TECHNOLOGY

Author

Schiano, C, Grimaldi, V, Aprile, M, Esposito, R, Maiello, C, Soricelli, A, Colantuoni, V, Costa, V, Ciccodicola, A, Napoli, C., Schiano, Concetta, Grimaldi, Vincenzo, Aprile, Marianna, Esposito, Roberta, Maiello, Ciro, Soricelli, Andrea, Colantuoni, Vittorio, Costa, Valerio, Ciccodicola, Alfredo, and Napoli, Claudio

Published
2016

33. Study Design and Preliminary Results of the Italian Everolimus Registry CERTIC

Author

Parisi F, Fiocchi R, Frigerio M, Gerosa G, Leonardi G, Livi U, Maccherini M, Maiello C., Rinaldi M, Vigano M, Colombo D, Brusa R, BRANZI, ANGELO, POTENA, LUCIANO, Parisi F, Branzi A, Fiocchi R, Frigerio M, Gerosa G, Leonardi G, Livi U, Maccherini M, Maiello C, Rinaldi M, Vigano M, Colombo D, Brusa R, and Potena L

Subjects
PRELIMINARY RESULTS, EVEROLIMUS, REGISTRY
Published
2012

34. Association between HLA-A26 and CMV infection in heart transplantation recipients

Author

Damiano, B, Sessa, M, Cesario, E, Di Mauro, T, Bibba, B, Ziello, F, Maiello, C, Romano, G, Cacciatore, F, BELSITO, Angela, FERRIERO, Maria Rosaria, CAIAFA, Ilaria, CONTE, Salvatore, SOMMESE, Linda, NAPOLI, Claudio, Wiley Blackwell, Damiano, B, Sessa, M, Cesario, E, Di Mauro, T, Belsito, Angela, Ferriero, Maria Rosaria, Bibba, B, Ziello, F, Caiafa, Ilaria, Conte, Salvatore, Sommese, Linda, Maiello, C, Romano, G, Cacciatore, F, and Napoli, Claudio

Published
2012

35. Biological properties of cardiac stem cells in normal and pathological conditions - matrix makes a difference

Author

MIRAGLIA, RITA, ROMANO, VERONICA, DI MEGLIO, FRANCA, NURZYNSKA, DARIA ANNA, CASTALDO, CLOTILDE, MONTAGNANI, STEFANIA, Sacco AM, Latino F, Bancone C, Amarelli C, Maiello C, Della Corte A, Miraglia, Rita, Sacco, Am, Romano, Veronica, Latino, F, DI MEGLIO, Franca, Nurzynska, DARIA ANNA, Castaldo, Clotilde, Bancone, C, Amarelli, C, Maiello, C, Della Corte, A, and Montagnani, Stefania

Abstract

Chronic ischemic heart disease is characterized by an imbalance between cardiac cell death and regeneration. The local non-invasive activation of cardiac stem cells offers the possibility to influence the course of cardiomyopathy and to inhibit or reverse the pathological remodelling. In patients with coronary artery disease, low energy shock wave (SW) therapy was found to improve symptoms and ameliorate ischemia. The aim of our study was to evaluate the effects of SW on cardiac resident primitive cells in vitro. CD117(+) cells were isolated from the atria of adult human normal (n=7, males, mean age 51±5.6 years) and pathological hearts with ischemic cardiomyopathy (n=11, males, mean age 55±3.2 years), and treated with 800 shots of SW at the energy flux density of 0.05mJ/mm². Phospho-MAPK protein expression was assayed with proteome profiler array after 1 hour and total mRNA was examined by signal transduction specific PCR-based array 72 hours after the treatment. Gene expression profiling revealed in CD117(+) cells from pathological heart the down-regulation of genes relevant to the hedgehog pathway (EN1, BMP4, FOXA2), that is active in the early stages of the developmental process, or belonging to the induction and positive regulation of programmed cell death functional groups (CDKN2A, CDKN2B, CDKN1A, TP53I3, TNF), while the transcriptionally up-regulated genes included CSF2, CCL20, BIRC3, IL8, and IL1A that are involved in NFκB survival pathway and CEBPB, HK2, LEP involved in insulin pathway and myogenesis. Although SW treatment resulted in the significant increase in phospho-ERK1/2 in both cell populations, the phosphorylation of its downstream substrate RSK1 increased only in the normal cells. Similarly, in the normal cells the phosphorylation of p38-MAPKα, β and γ increased 4, 4-, 1, 2- and 4,2-fold, respectively, while only 1,3- and 2,2-fold increase in phosphorylated p38α and γ was observed in pathological cells. Moreover, the prosurvival kinase Akt1 resulted activated only in the normal cells. We conclude that the application of SW activates survival pathways and protects from apoptosis, although different signal transduction pathways can be responsible for these effects in cardiac primitive cells from normal and pathological heart with ischemic cardiomyopathy.

Published
2012

42. Comunicazione orale: Trapianto cardiaco non complicato in paziente con infezione da HIV

Author

Maiello C, Pinto D, Sbreglia C, LIMONGELLI, Giuseppe, Amarelli C, Perrella A, Romano G, Marra C, Pacileo G, De Santo LS, UTILI, Riccardo, DURANTE MANGONI, Emanuele, Maiello, C, Pinto, D, Sbreglia, C, Limongelli, Giuseppe, Amarelli, C, Perrella, A, Romano, G, Marra, C, Pacileo, G, DE SANTO, Luca Salvatore, Utili, Riccardo, and DURANTE MANGONI, Emanuele

Published
2011

47. Interaction of alpha-6 integrin with laminin-1 is essential for cardiac regeneration mediated by cardiac primitive cells

Author

NURZYNSKA, DARIA ANNA, CASTALDO, CLOTILDE, DI MEGLIO, FRANCA, MIRAGLIA, RITA, MONTAGNANI, STEFANIA, Romano G., Maiello C., Mele V., Nurzynska, DARIA ANNA, Castaldo, Clotilde, DI MEGLIO, Franca, Miraglia, Rita, Romano, G., Maiello, C., Mele, V., and Montagnani, Stefania

Abstract

According to the recent findings, CD117(+) cells reside in the subepicardium and epicardially-derived cells may represent a population of cardiac primitive cells. We have previously shown the presence of laminin-1, typical of developing heart, in the subepicardium of human adult heart with chronic ischemic cardiomyopathy. Hence, the hypothesis arises that laminin-1 may influence cardiac primitive cells biology. CD117(+) cells from adult human heart were cultured on laminin-1, laminin-2 or albumin. Specific human alpha6 integrin small interfering RNA (siRNA) was used to examine the contribution of alpha6 integrin and laminin interactions to the cell proliferation, apoptosis and migration in vitro. Both laminin-1 and laminin-2 increased the proliferation of cells, as evaluated with BrdU incorporation. In the presence of laminin-2 the proliferation rate reached 7.9±0.4% (n=4), whereas during the culture of cardiac primitive cells on laminin-1 the incorporation of BrdU was over 4-fold higher (n=4, p

Published
2008

48. Preemptive strategy for the treatment of CMV infection. Lights and shadows on a 8 year single-centre experience of 260 patients

Author

UTILI, Riccardo, Amarelli C, Romano GP, De Santo LS, Marra C, Ursomando F, Mastroianni C, Casillo R, Ragone E, Maiello C, Cotrufo M., DURANTE MANGONI, Emanuele, Utili, Riccardo, Amarelli, C, Romano, Gp, DE SANTO, Luca Salvatore, Marra, C, Ursomando, F, Mastroianni, C, DURANTE MANGONI, Emanuele, Casillo, R, Ragone, E, Maiello, C, and Cotrufo, M.

Abstract

Abs #P180

Published
2007

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