title: The persistent exclusion of older patients from ongoing clinical trials regarding heart failure.
abstract: BACKGROUND
  Much clinical research of relevance to elderly patients examines individuals who are younger than those who have the disease in question. A good example is heart failure. Therefore, we investigated the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure.
  
  
  METHODS
  In the context of the Increasing the PaRticipation of the ElDerly in Clinical Trials (PREDICT) study, data from ongoing clinical trials regarding heart failure were extracted from the World Health Organization Clinical Trials Registry Platform on December 1, 2008. Main outcome measures were the proportion of trials excluding patients by an arbitrary upper age limit or by other exclusion criteria that might indirectly cause limited recruitment of older individuals. We classified exclusion criteria into 2 categories: justified or poorly justified.
  
  
  RESULTS
  Among 251 trials investigating treatments for heart failure, 64 (25.5%) excluded patients by an arbitrary upper age limit. Such exclusion was significantly more common in trials conducted in the European Union than in the United States (31/96 [32.3%] vs 17/105 [16.2%]; P = .007) and in drug trials sponsored by public institutions vs those by private entities (21/59 [35.6%] vs 5/36 [13.9%]; P = .02). Overall, 109 trials (43.4%) on heart failure had 1 or more poorly justified exclusion criteria that could limit the inclusion of older individuals. A similar proportion of clinical trials with poorly justified exclusion criteria was found in pharmacologic and nonpharmacologic trials.
  
  
  CONCLUSIONS
  Despite the recommendations of national and international regulatory agencies, exclusion of older individuals from ongoing trials regarding heart failure continues to be widespread.
authors: Institute of Gerontology and Geriatrics, Department of Clinical and Experimental Medicine, Policlinico Santa Maria della Misericordia, University of Perugia Medical School, Piazzale Menghini 1, 06156 Perugia PG, Italy. acherub@unipg.it
authors: Antonio
authors: A
authors: Cherubini
authors: Joaquim
authors: J
authors: Oristrell
authors: Xavier
authors: X
authors: Pla
authors: Carmelinda
authors: C
authors: Ruggiero
authors: Roberta
authors: R
authors: Ferretti
authors: Germán
authors: G
authors: Diestre
authors: A Mark
authors: AM
authors: Clarfield
authors: Peter
authors: P
authors: Crome
authors: Cees
authors: C
authors: Hertogh
authors: Vita
authors: V
authors: Lesauskaite
authors: Gabriel-Ioan
authors: GI
authors: Prada
authors: Katarzyna
authors: K
authors: Szczerbinska
authors: Eva
authors: E
authors: Topinkova
authors: Judith
authors: J
authors: Sinclair-Cohen
authors: David
authors: D
authors: Edbrooke
authors: Gary H
authors: GH
authors: Mills
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D016015:Logistic Models; D018579:Patient Selection