title: Prognostic effect of carbohydrate antigen 125-guided therapy in patients recently discharged for acute heart failure (CHANCE-HF). Study design.
abstract: OBJECTIVE
  Morbidity and mortality after admission for acute heart failure remain prohibitively high. In that setting, plasma levels of antigen carbohydrate 125 have shown to correlate with the severity of fluid overload and the risk of mortality and readmission. Preliminary data suggests a potential role of antigen carbohydrate 125 to guide therapy. The objective of this study is to evaluate the prognostic effect of an antigen carbohydrate 125-guided management strategy vs standard therapy in patients recently discharged for acute heart failure.
  
  
  METHODS
  This is a multicenter, randomized, single-blind, efficacy trial study of patients recently discharged from acute heart failure (< 180 days), New York Heart Association functional class II-IV and antigen carbohydrate 125 > 35 U/ml. A randomization scheme was used to allocate participants (in a 1:1 ratio) to receive therapy guided by antigen carbohydrate 125 (aiming to keep normal values) or standard treatment. Mainly, antigen carbohydrate 125-guided therapy is focused on the frequency of monitoring and titration of decongestive therapies and statins. As of December 10, 2013, there were 383 patients enrolled. The primary outcome was the composite of 1-year all-cause mortality or rehospitalization for acute heart failure. Analysis was planned to be intention-to-treat.
  
  
  CONCLUSIONS
  Discovering novel therapeutic strategies or finding better ways of optimizing established treatments have become a health care priority in heart failure. This study will add important knowledge about the potential of antigen carbohydrate 125 as a management tool for monitoring and titration of therapies where optimal utilization has not been well defined, such as diuretics and statins.
  
  
  BACKGROUND
  ClinicalTrials.gov number: NCT02008110.
authors.affiliation: Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, Valencia, Spain. Electronic address: yulnunez@gmail.com.
authors.forename: Julio
authors.initials: J
authors.lastname: Núñez
authors.affiliation: Servicio de Medicina Interna, Hospital de la Plana, Castellón, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Merlos
authors.affiliation: Servicio de Cardiología, Hospital General Universitario de Valencia, Valencia, Spain.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Fácila
authors.affiliation: Servicio de Medicina Interna, Hospital de Manises, Manises, Valencia, Spain.
authors.forename: Pau
authors.initials: P
authors.lastname: Llàcer
authors.affiliation: Servicio de Medicina Interna, Hospital de la Plana, Castellón, Spain.
authors.forename: Maria José
authors.initials: MJ
authors.lastname: Bosch
authors.affiliation: Servicio de Cardiología, Hospital de San Juan, San Juan de Alicante, Alicante, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Bertomeu-Martínez
authors.affiliation: Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Sergio
authors.initials: S
authors.lastname: García-Blas
authors.affiliation: Servicio de Cardiología, Hospital General Universitario de Valencia, Valencia, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Montagud
authors.affiliation: Servicio de Cardiología, Hospital de Manises, Manises, Valencia, Spain.
authors.forename: Valle
authors.initials: V
authors.lastname: Pedrosa
authors.affiliation: Servicio de Medicina Interna, Hospital de Manises, Manises, Valencia, Spain.
authors.forename: Andrea
authors.initials: A
authors.lastname: Mendizábal
authors.affiliation: Servicio de Cardiología, Hospital de San Juan, San Juan de Alicante, Alicante, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cordero
authors.affiliation: Servicio de Cardiología, Hospital de Manises, Manises, Valencia, Spain.
authors.forename: Gema
authors.initials: G
authors.lastname: Miñana
authors.affiliation: Servicio de Cardiología, Hospital Clínico Universitario, INCLIVA, Universitat de València, Valencia, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Sanchis
authors.affiliation: Servicio de Cardiología, Hospital de San Juan, San Juan de Alicante, Alicante, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Bertomeu-González
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D018394:CA-125 Antigen / Q000097:blood*; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002423:Cause of Death / Q000639:trends; D019468:Disease Management; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D010351:Patient Discharge / Q000639:trends*; D011379:Prognosis; D011446:Prospective Studies; D018570:Risk Assessment; D016037:Single-Blind Method; D013030:Spain / Q000453:epidemiology; D015996:Survival Rate / Q000639:trends; D013997:Time Factors
chemical_list: D015415:Biomarkers; D018394:CA-125 Antigen; D002317:Cardiovascular Agents
keywords: Antígeno carbohidrato 125; Biomarker guided-therapy; Carbohydrate antigen 125; Clinical outcomes; Clinical trial; Ensayo clínico; Heart failure; Insuficiencia cardiaca; Resultados clínicos; Tratamiento guiado por biomarcadores