Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SV‐INHIBITION study design

ESC Heart Failure

SV‐INHIBITION study investigators¹  Magalie Ladouceur²  Marie‐Christine Picot³  Marc Humbert⁴  Marilyne Levy⁵  Damien Bonnet⁵  Sophie Malekzadeh‐Milani⁵  Jean‐Benoit Thambo⁶  Hamouda Abassi⁷  Pascal Amedro⁷  Arthur Gavotto⁷  Stefan Matecki⁷  Alban‐Elouen Baruteau⁸  Clement Karsenty⁹  Caroline Ovaert^1,10  Philippe Aldebert^1,10  Sarah Cohen^1,11  Sebastien Hascoet^1,11  Alain Fraisse^1,12 

[1] ;Adult Congenital Heart Disease Unit, Department of Cardiology M3C National Reference Centre, European Hospital Georges Pompidou Paris France;Department of Epidemiology and Biostatistics CHU Montpellier Montpellier France;Department of Pulmonology PH National Reference Centre, APHP Kremlin‐Bicetre Paris France;Paediatric Cardiology Department, AP‐HP, Necker‐Enfants malades M3C National Reference Centre, Paris Descartes University, Sorbonne Paris Cite Paris France;Paediatric and Adult Congenital Heart Disease Department Hôpital Cardiologique du Haut‐Lévêque M3C National Reference Centre, CHU de Bordeaux Bordeaux France;Paediatric and Congenital Cardiology Department M3C Regional Reference CHD Centre, CHU Montpellier Montpellier France;Paediatric and Congenital Cardiology Department M3C Regional Reference CHD Centre, CHU Nantes Nantes France;Paediatric and Congenital Cardiology Department M3C Regional Reference CHD Centre, CHU Toulouse Toulouse France;Paediatric and Congenital Medico‐Surgical Cardiology Department M3C Regional Reference Centre, AP‐HM, La Timone University Hospital Marseille France;Paris‐Sud Faculty of Medicine, INSERM U999 Marie‐Lannelongue Hospital, M3C National Reference Centre, Paris‐Sud University, Paris‐Saclay Le Plessis‐Robinson Paris France;Pediatric Cardiology Service Royal Brompton and Harefield Hospital Trust London UK;

关键词: Congenital heart defect;    Single ventricle;    Pulmonary hypertension;    Sildenafil;    Pulmonary vasodilator;    Exercise capacity;   

DOI  :  10.1002/ehf2.12630

来源: DOAJ

【 摘 要 】

Abstract Aims 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. Methods and results 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/VCO2 slope, measured by a cardiopulmonary exercise test, between baseline and 6 months of treatment. A total of 50 patients are required to observe a decrease of 5 ± 5 points in the VE/VCO2 slope, with a power of 90% and an alpha risk of 5%. The secondary outcomes are clinical outcomes, oxygen saturation, 6 min walk test, SV function, NT‐proBNP, peak VO2, stroke volume, mean pulmonary arterial pressure, trans‐pulmonary gradient, SF36 quality of life score, safety, and acceptability. Conclusions 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).

【 授权许可】

Unknown