Comparación del tratamiento ambulatorio frente al tratamiento hospitalario en el paciente con insuficiencia cardiaca aguda

Antonio Luis Gámez-López , Juan Luis Bonilla-Palomas , María Cristina López-Ibáñez , Mirian Moreno-Conde , Carlos Javier Ráez-Ruiz , Rafaela Cruz-Arándiga , Juan Pedro Batres-Sicilia , Rocio Ruiz-Quirós , Blanca Herrador-Fuentes , Soledad Gómez-Cano
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Abstract

Introduction and objectives

Heart failure is a highly prevalent disease with a high morbidity and mortality. Episodes of acute episodes of heart failure during its natural history leads to a deterioration in the quality of life of these patients, as well as a worsening of their prognosis and the increased health costs, given that these patients have a high frequency of hospital admissions. The development of multidisciplinary heart failure units provides an intensive treatment and follow-up of the decompensated patient that prevents them being admitted in many cases. However, there are no studies that have evaluated the efficacy and safety of outpatient management compared to conventional hospital treatment. For this reason, the aim of this work is to compare the treatment of decompensations due to heart failure in the hospital setting with that of their outpatient treatment.

Method

Patients with acute heart failure without severity criteria will be enrolled and then randomised to either hospital or outpatient management. This will be a non-inferiority study, in which the primary outcome of the analysis is the time until death of cardiovascular origin, or re-admission due to heart failure in the first month of follow-up. It is estimated that 54 patients per group will be needed. The secondary outcomes collected will be: time until the combined event of admissions due to heart failure or death of cardiovascular origin at 6 months follow-up, a change in the level of perceived dyspnoea, and a comparison of the costs of each strategy. The estimated time to complete the current project is 24 months.

Conclusions

The current study will determine the safety and efficacy of the outpatient treatment of patients with acute heart failure.

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急性心力衰竭患者门诊治疗与住院治疗的比较
前言和目的心力衰竭是一种发病率和死亡率都很高的常见病。心衰急性发作在其自然史上的发作会导致这些患者生活质量的恶化,以及预后的恶化和医疗费用的增加,因为这些患者住院的频率很高。多学科心力衰竭单位的发展为失代偿患者提供了强化治疗和随访,在许多情况下阻止他们入院。然而,与传统的医院治疗相比,没有研究评估门诊管理的有效性和安全性。出于这个原因,这项工作的目的是比较治疗失代偿由于心力衰竭在医院设置与门诊治疗。方法纳入无严重程度标准的急性心力衰竭患者,随机分为住院组和门诊组。这将是一项非劣效性研究,其中分析的主要结局是在随访的第一个月内心血管源性死亡或因心力衰竭而再次入院的时间。据估计,每组需要54名患者。收集的次要结局将是:在随访6个月时,到因心力衰竭或心血管源性死亡而入院的合并事件的时间,感知到的呼吸困难水平的变化,以及每种策略的成本比较。预计完成当前项目的时间为24个月。结论本研究将确定门诊治疗急性心力衰竭患者的安全性和有效性。
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