PMID- 31371115
OWN - NLM
STAT- MEDLINE
DCOM- 20201123
LR  - 20201123
IS  - 1874-1754 (Electronic)
IS  - 0167-5273 (Linking)
VI  - 299
DP  - 2020 Jan 15
TI  - A single-centre, placebo-controlled, double-blind randomised cross-over study of 
      nebulised iloprost in patients with Eisenmenger syndrome: A pilot study.
PG  - 131-135
LID - S0167-5273(19)31450-0 [pii]
LID - 10.1016/j.ijcard.2019.07.004 [doi]
AB  - BACKGROUND: Pulmonary arterial hypertension (PAH), is a rare and progressive 
      disease with a high morbidity and mortality. Prostanoid pulmonary vasodilators 
      are the most effective treatment for idiopathic and connective tissue associated 
      PAH. Nonetheless, data examining their safety and efficacy in patients with 
      Eisenmenger syndrome the most severe form of PAH, that is, related to cyanotic 
      congenital heart disease (CHD-PAH) remains limited. AIM: To evaluate safety and 
      the clinical efficacy of nebulised iloprost in patients with Eisenmenger syndrome 
      who are on maximum background oral PAH therapy. METHODS: This pilot study was a 
      randomised, double-blind, placebo-controlled, cross-over study. Patients were 
      randomised to receive nebulised placebo or iloprost for 12 weeks and were then 
      crossed over, with a 7-14-day washout. The primary endpoint was a change in 
      6-minute walk distance (6MWD). RESULTS: Sixteen patients (11 females, aged 
      47.3 +/- 9.8 year) were recruited, twelve completed the study. All were in WHO-FC 
      III, with a resting oxygen saturation of 84 [81-87] % and a median 6MWD of 290 
      [260-300] m. There was no significant difference in the primary endpoint between 
      nebulised iloprost (0[-4-9]m) and placebo (10 [-15-51]m), p = 0.58. There were no 
      safety concerns with nebulised iloprost. CONCLUSIONS: Our pilot study provides 
      preliminary evidence that the addition of nebulised iloprost to maximum oral PAH 
      therapy did not improve the primary endpoint of 6MWD. Nebulised iloprost was well 
      tolerated with no significant safety concerns in CHD-PAH.
CI  - Copyright (c) 2019 Elsevier B.V. All rights reserved.
FAU - Nashat, Heba
AU  - Nashat H
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom; National Heart and 
      Lung Institute, Imperial College, London, United Kingdom.
FAU - Kempny, Aleksander
AU  - Kempny A
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom; National Heart and 
      Lung Institute, Imperial College, London, United Kingdom.
FAU - Harries, Carl
AU  - Harries C
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom.
FAU - Dormand, Natalie
AU  - Dormand N
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom.
FAU - Alonso-Gonzalez, Rafael
AU  - Alonso-Gonzalez R
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom; National Heart and 
      Lung Institute, Imperial College, London, United Kingdom.
FAU - Price, Laura C
AU  - Price LC
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom; National Heart and 
      Lung Institute, Imperial College, London, United Kingdom.
FAU - Gatzoulis, Michael A
AU  - Gatzoulis MA
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom; National Heart and 
      Lung Institute, Imperial College, London, United Kingdom.
FAU - Dimopoulos, Konstantinos
AU  - Dimopoulos K
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom; National Heart and 
      Lung Institute, Imperial College, London, United Kingdom.
FAU - Wort, Stephen J
AU  - Wort SJ
AD  - Adult Congenital Heart Disease Centre and National Centre for Pulmonary 
      Hypertension, Royal Brompton Hospital London, United Kingdom; National Heart and 
      Lung Institute, Imperial College, London, United Kingdom. Electronic address: 
      s.wort@imperial.ac.uk.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190704
PL  - Netherlands
TA  - Int J Cardiol
JT  - International journal of cardiology
JID - 8200291
RN  - 0 (Vasodilator Agents)
RN  - JED5K35YGL (Iloprost)
SB  - IM
MH  - Adult
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Eisenmenger Complex/diagnosis/*drug therapy/*physiopathology
MH  - Female
MH  - Humans
MH  - Iloprost/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - *Nebulizers and Vaporizers
MH  - Pilot Projects
MH  - Vasodilator Agents/*administration & dosage
MH  - Walk Test/methods
EDAT- 2019/08/03 06:00
MHDA- 2020/11/24 06:00
CRDT- 2019/08/03 06:00
PHST- 2019/03/28 00:00 [received]
PHST- 2019/06/18 00:00 [revised]
PHST- 2019/07/01 00:00 [accepted]
PHST- 2019/08/03 06:00 [pubmed]
PHST- 2020/11/24 06:00 [medline]
PHST- 2019/08/03 06:00 [entrez]
AID - S0167-5273(19)31450-0 [pii]
AID - 10.1016/j.ijcard.2019.07.004 [doi]
PST - ppublish
SO  - Int J Cardiol. 2020 Jan 15;299:131-135. doi: 10.1016/j.ijcard.2019.07.004. Epub 
      2019 Jul 4.