Heart Department, Cardiology Division, "Cava de' Tirreni and Amalfi Coast" Hospital, University of Salerno, Salerno, Italy.
Department of Translational Medical Sciences, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.
Intern Emerg Med. 2018 Aug;13(5):661-671. doi: 10.1007/s11739-018-1844-8. Epub 2018 Apr 4.
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 3 years. 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 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.
最近的证据支持这样一种概念，即慢性心力衰竭（CHF）的进展取决于分解代谢力量相对于合成代谢驱动力的不平衡。在这方面，多种激素缺乏综合征（MHDS）对 CHF 进展有显著影响，并与更差的临床状况和更高的死亡率相关。T.O.S.CA.（Trattamento Ormonale nello Scompenso CArdiaco；心力衰竭中的激素治疗）登记处（clinicaltrial.gov = NCT02335801）检验了这样一种假设，即合成代谢缺乏会降低大量轻度至中度 CHF 患者的生存率。T.O.S.CA. 登记处是一项由那不勒斯“费德里科二世”大学协调的前瞻性多中心观察性研究，涉及意大利各地的 19 个中心。在基线和每年测量甲状腺激素、胰岛素样生长因子-1、总睾酮、脱氢表雄酮和胰岛素，患者平均随访 3 年。CHF 患者分为两组：基线时有 1 种或无 1 种合成代谢缺乏的患者，以及基线时有 2 种或更多合成代谢缺乏的患者。主要终点是全因死亡率和心血管住院的复合终点。次要终点包括全因死亡率和住院的复合终点、心血管死亡率和心血管住院的复合终点以及 VO 峰值的变化。患者招募于 2013 年 4 月开始，于 2017 年 7 月完成。本文提供了入组患者的人口统计学和主要临床特征。详细的横断面结果将于 2018 年末公布。T.O.S.CA. 登记处代表了心力衰竭领域中 MHDS 最强大的前瞻性观察性试验。该研究结果将增进我们对 CHF 进展的内在机制的了解，并有望为心力衰竭中单激素或多激素替代治疗的未来随机临床试验铺平道路。
