title: How does a clinical trial fit into the real world? The RELAX-AHF study population into the EAHFE registry.
abstract: OBJECTIVE
  To test how accurate the recently published RELAX-AHF trial was in recruiting real-world patients with acute-decompensated heart failure (ADHF).
  
  
  RESULTS
  We compared clinical and outcome data of patients receiving serelaxin in the RELAX-AHF trial (RELAX group, n = 581) with patients included in the EAHFE registry [5497 ADHF from 29 Spanish emergency departments (EDs)]. The EAHFE registry was split into two groups: EAHFE-non-RELAX (patients not fulfilling the RELAX-AHF inclusion criteria; n = 3205, 58.3 %) and EAHFE-RELAX A (patients fulfilling RELAX-AHF inclusion criteria; n = 2292, 41.7 %). The latter group was further refined by also applying exclusion criteria (EAHFE-RELAX B; n = 964, 17.4 %). Both EAHFE-RELAX groups differed from the EAHFE-non-RELAX group in multiple aspects, with the lower the proportion of patients with implantable cardiac defibrillator and with pulmonary diseases the greater the differences found. The RELAX group, compared with the EAHFE-RELAX groups, significantly included fewer females, younger patients, less in NYHA class I/II, less with implantable cardiac defibrillator and on beta-blocker treatment, and patients had lower systolic blood pressure and cardiac and respiratory rates at ED arrival. The EAHFE-RELAX groups had a significantly lower all-cause mortality than EAHFE-non-RELAX group, and qualitative analysis suggested that EAHFE-RELAX groups had a higher mortality than the RELAX group.
  
  
  CONCLUSIONS
  Patients included in the RELAX-AHF trial showed unanticipated differences when compared with a population from the EAHFE registry fulfilling very similar inclusion and exclusion criteria.
authors.affiliation: Emergency Department, Hospital Clínic, Barcelona; "Emergencies: processes and pathologies" Research Group, IDIBAPS, Villarroel 170, 08036, Barcelona, Catalonia, Spain.
authors.forename: Òscar
authors.initials: Ò
authors.lastname: Miró
authors.affiliation: Emergency Department, Hospital Clínic, Barcelona; "Emergencies: processes and pathologies" Research Group, IDIBAPS, Villarroel 170, 08036, Barcelona, Catalonia, Spain. vgilespinosa@gmail.com.
authors.forename: Víctor
authors.initials: V
authors.lastname: Gil
authors.affiliation: Cardiology Department, Basel University, Basel, Switzerland.
authors.forename: Christian
authors.initials: C
authors.lastname: Müller
authors.affiliation: Department of Anesthesiology and Intensive Care, Lariboisière University Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, Paris, France.
authors.forename: Alexander
authors.initials: A
authors.lastname: Mebazaa
authors.affiliation: Hospital General Universitario Gregorio Marañón and Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
authors.forename: Héctor
authors.initials: H
authors.lastname: Bueno
authors.affiliation: Emergency Department, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Martín-Sánchez
authors.affiliation: Emergency Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Herrero
authors.affiliation: Emergency Department, Hospital universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Jacob
authors.affiliation: Emergency Department, Home Hospitalization and Short Stay Unit, Hospital General de Alicante, Alicante, Spain.
authors.forename: Pere
authors.initials: P
authors.lastname: Llorens
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D019317:Evidence-Based Medicine; D005260:Female; D006333:Heart Failure / Q000453:epidemiology*; D006801:Humans; D008297:Male; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012042:Registries; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013030:Spain / Q000453:epidemiology
keywords: Clinical trials; Emergency department; Heart failure; Registry