Department of Translational Medical Sciences, Federico II University, Via Sergio Pansini, 5, 80131 Naples, Italy.
Italian Clinical Outcome Research and Reporting Program (I-CORRP), Naples, Italy.
Eur J Prev Cardiol. 2021 Dec 29;28(15):1691-1700. doi: 10.1093/eurjpc/zwab020.
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.
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 < 0.001). Median follow-up was of 36 months. MHDS was independently associated with the occurrence of the primary endpoint [hazard ratio 95% (confidence interval), 1.93 (1.37-2.73), P < 0.001] and identified a group of patients with a higher mortality [2.2 (1.28-3.83), P = 0.01], with a graded relation between HDs and cumulative events (P < 0.01).
MHDS is common in CHF and independently associated with increased all-cause mortality and cardiovascular hospitalization, representing a promising therapeutic target.
ClinicalTrials.gov identifier: NCT023358017.
最近的证据支持慢性心力衰竭（CHF）中存在多种激素和代谢缺陷综合征（MHDS）。然而，尚无大型观察性研究明确证明其对 CHF 进展和结局的影响。T.O.S.CA.（Trattamento Ormonale nello Scompenso CArdiaco；心力衰竭的激素治疗）登记处专门设计用于检验以下假设，即 MHDS 影响 CHF 患者的发病率和死亡率。
T.O.S.CA. 登记处是一项前瞻性、多中心、观察性研究，涉及 19 个意大利中心。评估了甲状腺激素、胰岛素样生长因子-1、总睾酮、脱水去氢表雄酮硫酸盐、胰岛素抵抗和糖尿病的存在。MHDS 定义为存在≥2 种激素缺乏（HDs）。主要终点是全因死亡率和心血管住院的复合终点。共纳入 480 例射血分数≤45%的心力衰竭患者。372 例（77.5%）患者诊断为 MHDS 或糖尿病。共记录了 271 例事件（97 例死亡和 174 例心血管住院），NO-MHDS 组为 41%，MHDS 组为 62%（P<0.001）。中位随访时间为 36 个月。MHDS 与主要终点的发生独立相关[风险比 95%置信区间，1.93（1.37-2.73），P<0.001]，并确定了一组死亡率更高的患者[2.2（1.28-3.83），P=0.01]，HDs 与累积事件之间存在分级关系（P<0.01）。
MHDS 在 CHF 中很常见，与全因死亡率和心血管住院增加独立相关，是一个很有前途的治疗靶点。
ClinicalTrials.gov 标识符：NCT023358017。
