title: Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical trials.gov number: NCT01437371.
authors.affiliation: CHU Clermont-Ferrand, Service Cardiology, F-63000 Clermont-Ferrand. reschalier@chu-clermontferrand.fr
authors.forename: Romain
authors.initials: R
authors.lastname: Eschalier
authors.forename: Frédéric
authors.initials: F
authors.lastname: Jean
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.forename: Séverine
authors.initials: S
authors.lastname: Monzy
authors.forename: Charles
authors.initials: C
authors.lastname: Vorilhon
authors.forename: Valérie
authors.initials: V
authors.lastname: Mactoux
authors.forename: Bernard
authors.initials: B
authors.lastname: Citron
authors.forename: Vincent
authors.initials: V
authors.lastname: Sapin
authors.forename: Pascal
authors.initials: P
authors.lastname: Motreff
authors.forename: Jean R
authors.initials: JR
authors.lastname: Lusson
mesh_terms: D000367:Age Factors; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D019317:Evidence-Based Medicine / Q000191:economics; D005602:France; D019983:Guideline Adherence / Q000191:economics; D017048:Health Care Costs; D006333:Heart Failure / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D010359:Patient Readmission; D010865:Pilot Projects; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000191:economics; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome