Very Long-term Longitudinal Follow-up of Heart Failure on the REMADHE Trial

Edimar Alcides Bocchi, Guilherme Veiga Guimaraes, Cristian Espinoza, Silvia Moreira-Ferreira, Bruno Biselli, Paulo Chizzola, Robinson Mulhoz, Julia Tizue Fukushima, Fatima Cruz
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Abstract

Background: Heart failure (HF) is associated with frequent hospitalization and worse prognosis. Prognosis factors and survival in very long-term follow-up have not been reported in HF. HF disease management programs(DMP) results are contradictory. DMP efficacy in very long-term follow-up is unknown. We studied the very long-term follow-up of up to 23.6 years and prognostic factors of HF in 412 patients under GDMT included in the REMADHE trial. Methods: The REMADHE trial was a prospective, single-center, randomized trial comparing DMP versus usual care(C). The first patient was randomized on October 5, 1999. The primary outcome of this extended REMADHE was all-cause mortality. Results: The all-cause mortality rate was 88.3%. HF was the first cause of death followed by death at home. Mortality was higher in the first 6-year follow-up. The predictive variables in multivariate analysis associated with mortality were age >52 years (P=0.015), Chagas etiology (P=0.010), LVEF <45% (P=0.008), use of digoxin (P=0.002), functional class IV (P=0.01), increase in urea (P=0.03), and reduction of lymphocytes (P=0.005). In very long-term follow-up, DMP did not affect mortality in patients under GDMT. HF as a cause of death was more frequent in the C group. Chagas disease, LVEF <45%, and renal function were associated with different modes of death. Conclusion: DMP was not effective in reducing very-long term mortality; however, the causes of death had changed. Our findings that age, LVEF, Chagas disease, functional class, renal function, lymphocytes, and digoxin use were associated with poor prognosis could influence future strategies to improve HF management.
REMADHE 试验对心力衰竭的长期纵向随访
背景:心力衰竭(HF)与频繁住院和预后较差有关。目前还没有关于心力衰竭的预后因素和长期随访存活率的报道。心力衰竭疾病管理计划(DMP)的结果相互矛盾。DMP在长期随访中的疗效尚不清楚。我们研究了 REMADHE 试验中接受 GDMT 的 412 名患者长达 23.6 年的长期随访情况以及心房颤动的预后因素。研究方法REMADHE试验是一项前瞻性、单中心、随机试验,比较了DMP与常规护理(C)。第一例患者于 1999 年 10 月 5 日随机接受治疗。这次延长的 REMADHE 试验的主要结果是全因死亡率。试验结果全因死亡率为 88.3%。高血压是首要死因,其次是在家中死亡。头6年随访的死亡率较高。在多变量分析中,与死亡率相关的预测变量为年龄 52 岁(P=0.015)、恰加斯病因(P=0.010)、LVEF 45%(P=0.008)、使用地高辛(P=0.002)、功能分级 IV 级(P=0.01)、尿素增加(P=0.03)和淋巴细胞减少(P=0.005)。在长期随访中,DMP 并未影响 GDMT 患者的死亡率。C组患者的死因多为心房颤动。恰加斯病、LVEF <45%和肾功能与不同的死亡方式有关:结论:DMP 未能有效降低长期死亡率,但死亡原因发生了变化。我们的研究结果表明,年龄、LVEF、南美锥虫病、功能分级、肾功能、淋巴细胞和地高辛的使用与不良预后有关,这可能会影响未来改善高血压管理的策略。
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