CHU Clermont-Ferrand, Service Cardiology, F-63000 Clermont-Ferrand.
Trials. 2012 Mar 6;13:25. doi: 10.1186/1745-6215-13-25.
An aging population and better management of various heart diseases explain the exponential growth in incidence and prevalence of chronic heart failure, with poor prognosis and heavy health costs. Medical management is codified in international guidelines. The management of heart failure in over-80 year-old patients follows these guidelines, but no clinical trials have been able to confirm benefit. Moreover, registries show down-prescription of heart failure treatments in the elderly and over-80s.
METHODS/DESIGN: We present the design of the HF-80 ("Is there benefit in optimising heart failure treatment in over-80 year-old patients?") study, which is a prospective randomised open-label clinical trial with blinded end-points, designed to evaluate the effect of optimising management by adhering to guidelines in over-80 year-old heart failure patients. Patients over 80 years of age admitted with acute heart failure will be included. The primary endpoint is to assess quality of life at 6 months on the Minnesota questionnaire. The secondary endpoints are to assess the effect of optimised management on quality of life, mortality, readmission for acute heart failure, cardiac fibrosis and economic data at 12 months. 80 patients will be included, divided into 2 groups: group A, with usual heart failure management by general practitioners; and group B, with optimised management based on international guidelines.
It is necessary to assess the benefit of guidelines in over-80 year-old heart failure patients because of the fragility of this population and the elevated risk of iatrogenic complications.
Clinical trials.gov number: NCT01437371.
人口老龄化和各种心脏病的更好管理解释了慢性心力衰竭发病率和患病率的指数级增长，预后不良且医疗费用沉重。医学管理已被纳入国际指南。80 岁以上患者的心力衰竭管理遵循这些指南，但没有临床试验能够证实其获益。此外，注册研究表明，心力衰竭治疗在老年人和 80 岁以上人群中的处方量较低。
方法/设计：我们介绍了 HF-80（“优化 80 岁以上心力衰竭患者的治疗是否有益？”）研究的设计，这是一项前瞻性随机开放标签临床试验，具有盲终点，旨在评估通过遵循指南优化管理对 80 岁以上心力衰竭患者的影响。将纳入因急性心力衰竭入院的 80 岁以上患者。主要终点是在 6 个月时使用明尼苏达问卷评估生活质量。次要终点是评估优化管理对生活质量、死亡率、因急性心力衰竭再次入院、心脏纤维化和 12 个月时的经济数据的影响。将纳入 80 例患者，分为 2 组：A 组，由全科医生进行常规心力衰竭管理；B 组，根据国际指南进行优化管理。
由于该人群的脆弱性和医源性并发症的风险增加，有必要评估指南对 80 岁以上心力衰竭患者的获益。
ClinicalTrials.gov 编号：NCT01437371。
