PMID- 27465329
OWN - NLM
STAT- MEDLINE
DCOM- 20170403
LR  - 20181202
IS  - 1993-1352 (Electronic)
IS  - 1672-0733 (Linking)
VI  - 36
IP  - 4
DP  - 2016 Aug
TI  - Efficacy of Bosentan in patients after Fontan procedures: a double-blind, 
      randomized controlled trial.
PG  - 534-540
LID - 10.1007/s11596-016-1621-8 [doi]
AB  - Fontan surgery is a widely used palliative procedure that significantly improves 
      the survival period of patients with complex congenital heart disease (CHD). 
      However, it does not decrease postoperative complication rate. Previous studies 
      suggested that elevated mean pulmonary artery pressure (mPAP) and vascular 
      resistance lead to decreased exercise tolerance and myocardial dysfunction. 
      Therapy with endothelial receptor antagonists (Bosentan) has been demonstrated to 
      improve the patients' prognosis. A double-blind, randomized controlled trial was 
      performed to explore the efficacy of Bosentan in treating patients who underwent 
      the Fontan procedure. Eligible participants were randomly divided into Bosentan 
      group and control group. Liver function was tested at a local hospital and the 
      results were reported to the phone inspector every month. If the results 
      suggested abnormal liver function, treatment would be adjusted or terminated. All 
      the participants finished the follow-up study, with no patients lost to 
      follow-up. Unblinding after 2-year follow-up, no mortality was observed in either 
      group. However, secondary end-points were found to be significantly different in 
      the comparable groups. The cardiac function and 6-min walking distance in the 
      Bosentan group were significantly superior to those in the control group (P=0.018 
      and P=0.027). Bosentan could improve New York Heart Association (NYHA) functional 
      status and improve the results of the 6-min walking test (6MWT) in Fontan 
      patients post-surgery, and no other benefits were observed. Furthermore, a 
      primary meta-analysis study systematically reviewed all the similar clinical 
      trails worldwide and concluded an overall NYHA class improvement in Fontan 
      patients who received Bosentan treatments.
FAU - Shang, Xiao-Ke
AU  - Shang XK
AD  - Cardiac Surgery, Union Hospital, Tongji Medical College, Huazhong University of 
      Science and Technology, Wuhan, 430022, China.
FAU - Lu, Rong
AU  - Lu R
AD  - Cardiac Surgery, Union Hospital, Tongji Medical College, Huazhong University of 
      Science and Technology, Wuhan, 430022, China.
FAU - Zhang, Xi
AU  - Zhang X
AD  - SinoScript LLC, Vernon, Connecticut, 06066, USA.
FAU - Zhang, Chang-Dong
AU  - Zhang CD
AD  - Department of Intervention, Wuhan Asia Heart Hospital, Wuhan, 430022, China.
FAU - Xiao, Shu-Na
AU  - Xiao SN
AD  - Cardiac Surgery, Union Hospital, Tongji Medical College, Huazhong University of 
      Science and Technology, Wuhan, 430022, China.
FAU - Liu, Mei
AU  - Liu M
AD  - Department of Radiology, The Keck School of Medicine, University of Southern 
      California, California, 90033, USA.
FAU - Wang, Bin
AU  - Wang B
AD  - Cardiac Surgery, Union Hospital, Tongji Medical College, Huazhong University of 
      Science and Technology, Wuhan, 430022, China.
FAU - Dong, Nian-Guo
AU  - Dong NG
AD  - Cardiac Surgery, Union Hospital, Tongji Medical College, Huazhong University of 
      Science and Technology, Wuhan, 430022, China. yxsxs2015@sohu.com.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160728
PL  - China
TA  - J Huazhong Univ Sci Technolog Med Sci
JT  - Journal of Huazhong University of Science and Technology. Medical sciences = Hua 
      zhong ke ji da xue xue bao. Yi xue Ying De wen ban = Huazhong keji daxue xuebao. 
      Yixue Yingdewen ban
JID - 101169627
RN  - 0 (Sulfonamides)
RN  - Q326023R30 (Bosentan)
SB  - IM
MH  - Adolescent
MH  - Bosentan
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - *Fontan Procedure
MH  - Heart Defects, Congenital/*drug therapy/pathology/*surgery
MH  - Humans
MH  - Liver/*drug effects/pathology
MH  - Male
MH  - Palliative Care
MH  - Prognosis
MH  - Sulfonamides/*administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bosentan
OT  - Fontan procedure
OT  - prognosis
OT  - pulmonary hypertension
OT  - pulmonary vascular resistance
EDAT- 2016/07/29 06:00
MHDA- 2017/04/04 06:00
CRDT- 2016/07/29 06:00
PHST- 2015/02/27 00:00 [received]
PHST- 2016/06/15 00:00 [accepted]
PHST- 2016/07/29 06:00 [entrez]
PHST- 2016/07/29 06:00 [pubmed]
PHST- 2017/04/04 06:00 [medline]
AID - 10.1007/s11596-016-1621-8 [pii]
AID - 10.1007/s11596-016-1621-8 [doi]
PST - ppublish
SO  - J Huazhong Univ Sci Technolog Med Sci. 2016 Aug;36(4):534-540. doi: 
      10.1007/s11596-016-1621-8. Epub 2016 Jul 28.