PMID- 26975942
OWN - NLM
STAT- MEDLINE
DCOM- 20171109
LR  - 20181202
IS  - 1532-8414 (Electronic)
IS  - 1071-9164 (Linking)
VI  - 22
IP  - 7
DP  - 2016 Jul
TI  - Defining Advanced Heart Failure: A Systematic Review of Criteria Used in Clinical 
      Trials.
PG  - 569-77
LID - S1071-9164(16)00076-2 [pii]
LID - 10.1016/j.cardfail.2016.03.003 [doi]
AB  - BACKGROUND: Enrollment criteria used in advanced heart failure (HF) clinical 
      trials might identify a common set of widely accepted quantitative 
      characteristics as the basis of a consensus definition for advanced HF, which is 
      currently lacking. METHODS: We reviewed all clinical trials investigating 
      interventions in patients with advanced HF as of July 31, 2015. Eligible 
      publications (N = 134) reported original data from clinical trials explicitly 
      defining advanced HF in adults. RESULTS: New York Heart Association (NYHA) class 
      was the most common criterion (119 trials, 88.8%; classes ranged from II to IV), 
      followed by left ventricular ejection fraction (LVEF) (84 trials, 62.7%; cutoff 
      range, 20% to 45%; mode 35%). Other criteria included inotrope-dependent status 
      (12.7%), peak oxygen consumption (10.4%), >/=1 previous HF admissions (10.4%), 
      cardiac index (10.4%), pulmonary capillary wedge pressure (9.0%), left 
      ventricular end-diastolic diameter (6.0%), and transplant listing status (5.2%). 
      Cutoff points for quantitative criteria varied considerably. Previous HF 
      admission was more frequently required in recent trials (P = .007 for temporal 
      trend), whereas use of hemodynamic criteria decreased over time (P = .050 for 
      temporal trend). Average LVEF among participants increased over time. 
      CONCLUSIONS: There is considerable variation in the definition of advanced HF for 
      clinical trial purposes. Beyond NYHA and LVEF, a wide array of criteria has been 
      used, with little consistency both in criteria selection and quantitative cutoff 
      points.
CI  - Copyright (c) 2016 Elsevier Inc. All rights reserved.
FAU - Bjork, Jonathan B
AU  - Bjork JB
AD  - Emory University, Atlanta, Georgia.
FAU - Alton, Kristina K
AU  - Alton KK
AD  - Emory University, Atlanta, Georgia.
FAU - Georgiopoulou, Vasiliki V
AU  - Georgiopoulou VV
AD  - Emory University, Atlanta, Georgia.
FAU - Butler, Javed
AU  - Butler J
AD  - Stony Brook University, Stony Brook, New York.
FAU - Kalogeropoulos, Andreas P
AU  - Kalogeropoulos AP
AD  - Emory University, Atlanta, Georgia. Electronic address: akaloge@emory.edu.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20160311
PL  - United States
TA  - J Card Fail
JT  - Journal of cardiac failure
JID - 9442138
SB  - IM
MH  - *Clinical Trials as Topic
MH  - Heart Failure/*classification/diagnosis/physiopathology
MH  - Humans
MH  - *Patient Selection
MH  - Stroke Volume
OTO - NOTNLM
OT  - Heart failure
OT  - advanced heart failure
OT  - clinical trials
OT  - systematic review
EDAT- 2016/03/16 06:00
MHDA- 2017/11/10 06:00
CRDT- 2016/03/16 06:00
PHST- 2015/10/28 00:00 [received]
PHST- 2016/03/02 00:00 [revised]
PHST- 2016/03/07 00:00 [accepted]
PHST- 2016/03/16 06:00 [entrez]
PHST- 2016/03/16 06:00 [pubmed]
PHST- 2017/11/10 06:00 [medline]
AID - S1071-9164(16)00076-2 [pii]
AID - 10.1016/j.cardfail.2016.03.003 [doi]
PST - ppublish
SO  - J Card Fail. 2016 Jul;22(7):569-77. doi: 10.1016/j.cardfail.2016.03.003. Epub 
      2016 Mar 11.