Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial

Romain Eschalier, Frédéric Jean, Bruno Pereira, Séverine Monzy, Charles Vorilhon, Valérie Mactoux, Bernard Citron, Vincent Sapin, Pascal Motreff, Jean R Lusson, Romain Eschalier, Frédéric Jean, Bruno Pereira, Séverine Monzy, Charles Vorilhon, Valérie Mactoux, Bernard Citron, Vincent Sapin, Pascal Motreff, Jean R Lusson

Abstract

Background: 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.

Discussion: 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.

Trial registration: Clinical trials.gov number: NCT01437371.

Figures

Figure 1
Figure 1
Flow chart describing HF 80 study design. HF: heart failure.
Figure 2
Figure 2
Flow chart describing HF 80 study investigational procedure. CE: clinical examination; EKG: electrocardiogram; MMSE: mini mental state examination; QOL: quality of life scale; 6MWT: 6 minutes walking test; Seattle HF: Seattle heart failure score; TTE: transthoracic echocardiography.

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