The TOSCA Registry: Hormonal and Metabolic Deficiencies in Chronic Heart Failure (TOSCA)
2018年12月11日 更新者：Antonio Cittadini、Federico II University
The TOSCA Registry: Epidemiology, Clinical and Prognostic Value of Hormonal and Metabolic Deficiencies in Chronic Heart Failure
The objective of this study is to determine whether the presence of metabolic alteration and anabolic deficiencies in patients with chronic heart failure are able to identify a subset of patients with poor outcome.
研究概览
地位
未知
条件
详细说明
Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.
Aim of this registry is to determine the prevalence of hormone/metabolic deficiencies in heart failure patients and to look for possible association with clinical variables. Moreover, enrolled patients will be followed up for a mean of 2,5 years in order to collect outcome data including all-cause mortality, cardiovascular mortality, hospitalizations.
This is a multi-center observational study involving several Italian Department of Cardiology, Endocrinology, Internal Medicine
研究类型
观察性的
注册 (预期的)
650
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Bari、意大利
- 招聘中
- Policlinico di Bari
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接触：
- Massimo Iacoviello, MD
- 邮箱：massimo.iacoviello@cardio.uniba.it
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接触：
- Vincenzo Triggiani, MD
- 邮箱：v.triggiani@endo.uniba.it
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Catania、意大利
- 招聘中
- Policlinico "Vittorio Emanuele" University of Catania
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接触：
- Ines Monte, MD
- 邮箱：inemonte@unict.it
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Catanzaro、意大利
- 招聘中
- Unità Operativa di Malattie Cardiovascolari del Policlinico Mater Domini
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接触：
- Francesco Perticone
- 邮箱：perticone@unicz.it
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接触：
- Antonio Belfiore
- 邮箱：belfiore@unicz.it
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Enna、意大利
- 招聘中
- UOC di Medicina Interna IRCCS Oasi Maria SS
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接触：
- Letizia Ragusa, MD
- 邮箱：lragusa@oasi.en.it
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Ferrara、意大利
- 招聘中
- UOC Clinica Medica Dipartimento ad Attività Integrata di Medicina Azienda Ospedaliera-Universitaria S.Anna
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接触：
- Roberto Manfredini, MD
- 邮箱：roberto.manfredini@unife.it
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Florence、意大利
- 尚未招聘
- University of Florence
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接触：
- Pietro Amedeo Modesti, MD
- 邮箱：pamodesti@unifi.it
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Milan、意大利
- 招聘中
- IRCCS Policlinico San Donato Milanese
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接触：
- Michele Arcopinto, MD
- 邮箱：michele.arcopinto83@gmail.com
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Naples、意大利、80100
- 招聘中
- Department of Traslational Sciences - Federico II University
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接触：
- Antonio Cittadini, MD
- 电话号码：+39 081 7464375
- 邮箱：antonio.cittadini@unina.it
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接触：
- Michele Arcopinto, MD
- 电话号码：+39 339 7707531
- 邮箱：michele.arcopinto83@gmail.com
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Napoli、意大利
- 招聘中
- AORN V. Monaldi SUN - Centro di diagnosi e cura Cardiomiopatie e Scompenso Cardiaco
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接触：
- Giuseppe Limongelli, MD
- 邮箱：limongelligiuseppe@libero.it
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Napoli、意大利
- 招聘中
- Dipartimento di Scienze Biomediche Avanzate Università degli studi di Napoli Federico II
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接触：
- Pasquale Perrone-Filardi, MD
- 邮箱：pasquale.perronefilardi@unina.it
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Palermo、意大利
- 尚未招聘
- U.O.S. Endocrinologia Ospedali Riuniti "Villa Sofia - Cervello"
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接触：
- Graziella Malizia, MD
- 邮箱：graziella.malizia@alice.it
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接触：
- Piernicola Garofalo, MD
- 邮箱：piernicolagarofalo@alice.it
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Rome、意大利
- 招聘中
- U.O. di Riabilitazione Cardiologica IRCCS S. Raffaele Pisana
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接触：
- Maurizio Volterrani, MD
- 邮箱：maurizio.volterrani@sanraffaele.it
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Rome、意大利
- 招聘中
- UOC Endocrinologia e Malattie del Metabolismo Policlinico Universitario Gemelli
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接触：
- Antonio Mancini, MD
- 邮箱：mancini.giac@mclink.it
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Salerno、意大利
- 招聘中
- U.O. di Cardiologia e UTIC Ospedale S. Maria Incoronata dell'Olmo
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接触：
- Eduardo Bossone, MD, PhD
- 邮箱：ebossone@hotmail.com
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接触：
- Francesco Ferrara, MD
- 邮箱：francesco.ferrara30@tin.it
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Verona、意大利
- 招聘中
- Medicina Generale ad Indirizzo Endocrinologico - d.O. Azienda Ospedaliera Universitaria Integrata
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接触：
- Roberto Castello, MD
- 邮箱：roberto.castello@ospedaleuniverona.it
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Bari
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Cassano delle Murge、Bari、意大利
- 招聘中
- U.O. di Cardiologia 2 IRCCS-Istituto Scientifico di Riabilitazione di Cassano delle Murge
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接触：
- Andrea Passantino, MD
- 邮箱：andrea.passantino@fsm.it
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Napoli
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Nola、Napoli、意大利
- 招聘中
- Santa Maria della Pietà Hospital
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接触：
- Luigi Caliendo, MD
- 邮箱：l.caliendo@alice.it
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接触：
- Luciano Carbone, MD
- 邮箱：luciano_carbone@virgilio.it
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
patients with stable chronic heart failure with reduced ejection fraction
描述
Inclusion Criteria:
- patients of either sex affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
- left ventricle ejection fraction 40% or less
Exclusion Criteria:
- severe liver disease
- serum creatinine levels >2.5 mg/dl
- history of active cancer with life expectancy below 1 year
- acute coronary syndrome in the previous 6 months
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
all-cause mortality and hospitalization
大体时间：every six months (up to 5 years)
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outcome assessed during scheduled visits or phone calls
|
every six months (up to 5 years)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cardiovascular mortality
大体时间：every six months (up to 5 years)
|
outcome assessed during scheduled visits or phone calls
|
every six months (up to 5 years)
|
|
cardiovascular hospitalizations
大体时间：every six months (up to 5 years)
|
outcome assessed during scheduled visits or phone calls
|
every six months (up to 5 years)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
reduction in peak oxygen consumption
大体时间：every six months (up to 5 years)
|
outcome assessed during scheduled visits
|
every six months (up to 5 years)
|
|
left ventricular volumes
大体时间：every six months (up to 5 years)
|
outcome assessed during scheduled visits
|
every six months (up to 5 years)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Antonio Cittadini、Federico II University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cittadini A, Saldamarco L, Marra AM, Arcopinto M, Carlomagno G, Imbriaco M, Del Forno D, Vigorito C, Merola B, Oliviero U, Fazio S, Sacca L. Growth hormone deficiency in patients with chronic heart failure and beneficial effects of its correction. J Clin Endocrinol Metab. 2009 Sep;94(9):3329-36. doi: 10.1210/jc.2009-0533. Epub 2009 Jul 7.
- Bossone E, Limongelli G, Malizia G, Ferrara F, Vriz O, Citro R, Marra AM, Arcopinto M, Bobbio E, Sirico D, Caliendo L, Ballotta A, D'Andrea A, Frigiola A, Isgaard J, Sacca L, Antonio C; T.O.S.CA. Investigators. The T.O.S.CA. Project: research, education and care. Monaldi Arch Chest Dis. 2011 Dec;76(4):198-203. doi: 10.4081/monaldi.2011.177.
- Arcopinto M, Isgaard J, Marra AM, Formisano P, Bossone E, Vriz O, Vigorito C, Sacca L, Douglas PS, Cittadini A. IGF-1 predicts survival in chronic heart failure. Insights from the T.O.S.CA. (Trattamento Ormonale Nello Scompenso CArdiaco) registry. Int J Cardiol. 2014 Oct 20;176(3):1006-8. doi: 10.1016/j.ijcard.2014.07.003. Epub 2014 Jul 11. No abstract available.
- Cittadini A, Marra AM, Arcopinto M, Bobbio E, Salzano A, Sirico D, Napoli R, Colao A, Longobardi S, Baliga RR, Bossone E, Sacca L. Growth hormone replacement delays the progression of chronic heart failure combined with growth hormone deficiency: an extension of a randomized controlled single-blind study. JACC Heart Fail. 2013 Aug;1(4):325-330. doi: 10.1016/j.jchf.2013.04.003. Epub 2013 Aug 5.
- Salzano A, D'Assante R, Iacoviello M, Triggiani V, Rengo G, Cacciatore F, Maiello C, Limongelli G, Masarone D, Sciacqua A, Filardi PP, 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; T.O.S.CA. Investigators. Progressive right ventricular dysfunction and exercise impairment in patients with heart failure and diabetes mellitus: insights from the T.O.S.CA. Registry. Cardiovasc Diabetol. 2022 Jun 16;21(1):108. doi: 10.1186/s12933-022-01543-3.
- Cittadini A, Salzano A, Iacoviello M, Triggiani V, Rengo G, Cacciatore F, Maiello C, Limongelli G, Masarone D, Perticone F, Cimellaro A, Perrone Filardi P, Paolillo S, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Monte IP, Puzzo A, Ballotta A, D'Assante R, Arcopinto M, Gargiulo P, Sciacqua A, Bruzzese D, Colao A, Napoli R, Suzuki T, Eagle KA, Ventura HO, Marra AM, Bossone E; T.O.S.CA. Investigators. Multiple hormonal and metabolic deficiency syndrome predicts outcome in heart failure: the T.O.S.CA. Registry. Eur J Prev Cardiol. 2021 Dec 29;28(15):1691-1700. doi: 10.1093/eurjpc/zwab020.
- 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 PA, De Giorgi A, Monte I, Puzzo A, Ballotta A, Caliendo L, D'Assante R, Marra AM, Salzano A, Suzuki T, Cittadini A; TOSCA Investigators. Multiple hormonal and metabolic deficiency syndrome in chronic heart failure: rationale, design, and demographic characteristics of the T.O.S.CA. Registry. Intern Emerg Med. 2018 Aug;13(5):661-671. doi: 10.1007/s11739-018-1844-8. Epub 2018 Apr 4.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (实际的)
2015年6月1日
研究完成 (预期的)
2019年12月1日
研究注册日期
首次提交
2014年12月9日
首先提交符合 QC 标准的
2015年1月9日
首次发布 (估计)
2015年1月12日
研究记录更新
最后更新发布 (实际的)
2018年12月13日
上次提交的符合 QC 标准的更新
2018年12月11日
最后验证
2018年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.