Evidence map›Paper›PMID 32147955›Full record

ArticleESC heart failure2020

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

Pascal Amedro, Arthur Gavotto, Hamouda Abassi, Marie-Christine Picot, Stefan Matecki, Sophie Malekzadeh-Milani, Marilyne Levy, Magalie Ladouceur, Caroline Ovaert, Philippe Aldebert and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in ESC heart failure, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03997097 (Phosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03997097 phase3withdrawnnot on this mapstarted 2023, after this paper: background citation

Phosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III Study

TypeinterventionalSponsorUniversity Hospital, MontpellierRan2023 to 2028Enrolled0ConditionsSingle-ventricle, Pulmonary Hypertension, Univentricular HeartArmsSildenafil, Placebos
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 13 citations in OpenAlex.

  1. Impact of COVID-19 disease on clinical research in pediatric and congenital cardiology.Archives de pediatrie : organe officiel de la Societe francaise de pediatrie · 2022
    Observational
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 12 institutions in 3 countries.

Pascal AmedroPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, CHU Montpellier, Montpellier, France.
Arthur GavottoPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, CHU Montpellier, Montpellier, France.
Hamouda AbassiPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, CHU Montpellier, Montpellier, France.
Marie-Christine PicotDepartment of Epidemiology and Biostatistics, CHU Montpellier, Montpellier, France.
Stefan MateckiPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, CHU Montpellier, Montpellier, France.
Sophie Malekzadeh-MilaniPaediatric Cardiology Department, AP-HP, Necker-Enfants malades, M3C National Reference Centre, Paris Descartes University, Sorbonne Paris Cite, Paris, France.
Marilyne LevyPaediatric Cardiology Department, AP-HP, Necker-Enfants malades, M3C National Reference Centre, Paris Descartes University, Sorbonne Paris Cite, Paris, France.
Magalie LadouceurAdult Congenital Heart Disease Unit, Department of Cardiology, M3C National Reference Centre, European Hospital Georges Pompidou, Paris, France.
Caroline OvaertPaediatric and Congenital Medico-Surgical Cardiology Department, M3C Regional Reference Centre, AP-HM, La Timone University Hospital, Marseille, France.
Philippe AldebertPaediatric and Congenital Medico-Surgical Cardiology Department, M3C Regional Reference Centre, AP-HM, La Timone University Hospital, Marseille, France.
Jean-Benoit ThamboPaediatric and Adult Congenital Heart Disease Department, Hôpital Cardiologique du Haut-Lévêque, M3C National Reference Centre, CHU de Bordeaux, Bordeaux, France.
Alain FraissePediatric Cardiology Service, Royal Brompton and Harefield Hospital Trust, London, UK.
Marc HumbertDepartment of Pulmonology, PH National Reference Centre, APHP, Kremlin-Bicetre, Paris, France.
Sarah CohenParis-Sud Faculty of Medicine, INSERM U999, Marie-Lannelongue Hospital, M3C National Reference Centre, Paris-Sud University, Paris-Saclay, Le Plessis-Robinson, Paris, France.
Alban-Elouen BaruteauPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, CHU Nantes, Nantes, France.
Clement KarsentyPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, CHU Toulouse, Toulouse, France.
Damien BonnetPaediatric Cardiology Department, AP-HP, Necker-Enfants malades, M3C National Reference Centre, Paris Descartes University, Sorbonne Paris Cite, Paris, France.
Sebastien HascoetParis-Sud Faculty of Medicine, INSERM U999, Marie-Lannelongue Hospital, M3C National Reference Centre, Paris-Sud University, Paris-Saclay, Le Plessis-Robinson, Paris, France.
SV-INHIBITION study investigators
Centre Hospitalier Universitaire de Montpellier · FRAssistance Publique Hôpitaux de Marseille · FRDélégation Paris 5 · FRHôpital Marie Lannelongue · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Toulouse · FRCentre National de la Recherche Scientifique · FRHarefield Hospital · GBHôpital Cardiologique du Haut-Lévêque · FRHôpital Européen Georges-Pompidou · FRUniversité Paris-Sud · FR

Funding

French Department of Health DGOS-PHRC-N-2017
6 · The paper itself

Abstract

aimsIn 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

resultsThe 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

conclusionsThe 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).

Indexed as

Heart Defects, CongenitalHeart FailureUniventricular HeartAdolescentAdultHumansMulticenter Studies as TopicPhosphodiesterase 5 InhibitorsQuality of LifeRandomized Controlled Trials as TopicPhosphodiesterase 5 InhibitorsCongenital heart defectExercise capacityPulmonary hypertensionPulmonary vasodilatorSildenafilSingle ventricle

Identifiers

PMID32147955
PMCPMC7160497
OpenAlexW3009278749

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.