Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SV-INHIBITION study design.
Congenital heart defect
Exercise capacity
Pulmonary hypertension
Pulmonary vasodilator
Sildenafil
Single ventricle
Journal
ESC heart failure
ISSN: 2055-5822
Titre abrégé: ESC Heart Fail
Pays: England
ID NLM: 101669191
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
03
12
2019
revised:
04
01
2020
accepted:
12
01
2020
pubmed:
10
3
2020
medline:
22
6
2021
entrez:
10
3
2020
Statut:
ppublish
Résumé
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV) remains limited. We present the SV-INHIBITION study rationale, design, and methods. The SV-INHIBITION trial is a nationwide multicentre, randomized, double blind, placebo-controlled, Phase III study, aiming to evaluate the efficacy of sildenafil on the ventilatory efficiency during exercise, in teenagers and adult patients (>15 years old) with an SV. Patients with a mean pulmonary arterial pressure >15 mmHg and a trans-pulmonary gradient >5 mmHg, measured by cardiac catheterization, will be eligible. The primary outcome is the variation of the VE/VCO The SV-INHIBITION study aims to answer the question whether PDE5 inhibitors should be prescribed in patients with an SV. This trial has been built focusing on the three levels of research defined by the World Health Organization: disability (exercise tolerance), deficit (SV function), and handicap (quality of life).
Identifiants
pubmed: 32147955
doi: 10.1002/ehf2.12630
pmc: PMC7160497
doi:
Substances chimiques
Phosphodiesterase 5 Inhibitors
0
Banques de données
ClinicalTrials.gov
['NCT03997097']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
747-756Subventions
Organisme : French Department of Health
ID : DGOS-PHRC-N-2017
Pays : International
Informations de copyright
© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
Références
Pediatr Crit Care Med. 2014 Jan;15(1):28-34
pubmed: 24201857
Kardiol Pol. 2012;70(2):201-3
pubmed: 22427096
Cardiol Young. 2016 Jun;26(5):842-50
pubmed: 26947621
J Cardiovasc Med (Hagerstown). 2015 Aug;16(8):552-5
pubmed: 23588032
Heart. 2016 Jul 15;102(14):1081-6
pubmed: 27220691
Ann Thorac Surg. 2008 Sep;86(3):882-8; discussion 882-8
pubmed: 18721577
Cardiol Young. 2009 Aug;19(4):331-9
pubmed: 19519964
Cardiol Young. 2016 Oct;26(7):1250-9
pubmed: 26980152
Future Cardiol. 2012 Mar;8(2):271-84
pubmed: 22413985
Eur J Heart Fail. 2013 Jun;15(6):690-8
pubmed: 23361871
Int J Cardiol. 2016 Oct 15;221:122-7
pubmed: 27400308
Pediatr Cardiol. 2016 Jan;37(1):184-91
pubmed: 26409473
ESC Heart Fail. 2020 Apr;7(2):747-756
pubmed: 32147955
Cardiovasc Ther. 2018 Feb;36(1):
pubmed: 29193758
Pediatr Crit Care Med. 2013 Jul;14(6):593-600
pubmed: 23823195
Int J Cardiol. 2016 Jan 15;203:1052-60
pubmed: 26638054
Am Heart J. 2010 Dec;160(6):1004-14
pubmed: 21146651
Pediatr Cardiol. 2012 Jun;33(5):689-96
pubmed: 22331056
Wien Klin Wochenschr. 1995;107(23):714-7
pubmed: 8560892
J Am Heart Assoc. 2016 Sep 24;5(9):
pubmed: 27664807
Circulation. 2011 Mar 22;123(11):1185-93
pubmed: 21382896
Arch Cardiovasc Dis. 2017 May;110(5):346-353
pubmed: 28237697
Eur Respir J. 2017 Sep 9;50(3):
pubmed: 28889107
Pulm Circ. 2019 Jan-Mar;9(1):2045894018790450
pubmed: 29972332
Int Heart J. 2015;56 Suppl:S26-30
pubmed: 25787795
Pediatr Cardiol. 2013 Oct;34(7):1739-42
pubmed: 22806713
Heart. 2018 Jun;104(12):1026-1036
pubmed: 29170358
Eur J Heart Fail. 2019 Jun;21(6):803-809
pubmed: 30672076
Cardiol Young. 2010 Oct;20(5):522-5
pubmed: 20519058
Int J Cardiol. 2019 May 15;283:112-118
pubmed: 30616811
Circulation. 2014 Dec 2;130(23):2021-30
pubmed: 25446057