Evidence map›Paper›PMID 31836196›Full record

Trial reportLancet (London, England)2019

Irbesartan in Marfan syndrome (AIMS): a double-blind, placebo-controlled randomised trial.

Michael Mullen, Xu Yu Jin, Anne Child, A Graham Stuart, Matthew Dodd, José Antonio Aragon-Martin, David Gaze, Anatoli Kiotsekoglou, Li Yuan, Jiangting Hu and 10 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 6 pooled it
12.7field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 6 syntheses or guidelines pooled it, 128 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. Guideline
  5. Guideline
  6. Pooled it
  7. D-dimer in Marfan syndrome: effect of obstructive sleep apnea induced blood pressure surges.American journal of physiology. Heart and circulatory physiology · 2022
    Trial
  8. Trial
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Observational
  19. Review
  20. Article

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 15 institutions in 4 countries.

Michael MullenBarts Heart Centre, Barts Health NHS Trust, London, UK; Department of Cardiovascular Medicine and Devices, Queen Mary University, London, UK.
Xu Yu JinCore Echo Lab, Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Oxford Heart Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Anne ChildMolecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
A Graham StuartHeart Institute, University of Bristol, Bristol, UK.
Matthew DoddClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
José Antonio Aragon-MartinMolecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
David GazeDepartment of Life Sciences, University of Westminster, London UK.
Anatoli KiotsekoglouCore Echo Lab, Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Oxford Heart Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; School of Medical Sciences, Örebro University, Örebro, Sweden.
Li YuanCore Echo Lab, Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Oxford Heart Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Ultrasound Department, Wuhan Children's Hospital, Tongji Medical School, Huazhong University of Science and Technology, Hubei, China.
Jiangting HuCore Echo Lab, Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Oxford Heart Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Claire FoleyNHS Blood and Transplant, Cambridge, UK.
Laura Van DyckClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
Rosemary KnightClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
Tim ClaytonClinical Trials Unit, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
Lorna SwanDepartment of Adult Congenital Heart Disease, Royal Brompton and Harefield NHS Foundation Trust, London, UK; Toronto Congenital Cardiac Centre for Adults, Toronto, Canada.
John D R ThomsonDepartment of Cardiology, Leeds General Infirmary, Leeds, UK.
Guliz ErdemDepartment of Cardiology, Acibadem International Hospital Istanbul, Turkey; School of Medicine, Acibadem University, Istanbul, Turkey.
David CrossmanSchool of Medicine, University of St Andrews, St Andrews, UK.
Marcus FlatherNorwich Medical School, University of East Anglia, Norfolk, Norwich, UK; Cardiology Department, Norfolk and Norwich University Hospital, Norwich, UK. Electronic address: m.flather@uea.ac.uk.
AIMS Investigators
Leeds General Infirmary · GBLondon School of Hygiene & Tropical Medicine · GBJohn Radcliffe Hospital · GBSt George's, University of London · GBUniversity of St Andrews · GBAcıbadem University · TRBarts Health NHS Trust · GBNIHR Bristol Cardiovascular Biomedical Research Unit · GBQueen Mary University of London · GBNHS Blood and Transplant · GBNorfolk and Norwich University Hospital · GBRoyal Brompton & Harefield NHS Foundation Trust · GBUniversity of Bristol · GBUniversity of Westminster · GBWuhan Children's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIrbesartan, a long acting selective angiotensin-1 receptor inhibitor, in Marfan syndrome might reduce aortic dilatation, which is associated with dissection and rupture. We aimed to determine the effects of irbesartan on the rate of aortic dilatation in children and adults with Marfan syndrome.

methodsWe did a placebo-controlled, double-blind randomised trial at 22 centres in the UK. Individuals aged 6-40 years with clinically confirmed Marfan syndrome were eligible for inclusion. Study participants were all given 75 mg open label irbesartan once daily, then randomly assigned to 150 mg of irbesartan (increased to 300 mg as tolerated) or matching placebo. Aortic diameter was measured by echocardiography at baseline and then annually. All images were analysed by a core laboratory blinded to treatment allocation. The primary endpoint was the rate of aortic root dilatation. This trial is registered with ISRCTN, number ISRCTN90011794.

findingsBetween March 14, 2012, and May 1, 2015, 192 participants were recruited and randomly assigned to irbesartan (n=104) or placebo (n=88), and all were followed for up to 5 years. Median age at recruitment was 18 years (IQR 12-28), 99 (52%) were female, mean blood pressure was 110/65 mm Hg (SDs 16 and 12), and 108 (56%) were taking β blockers. Mean baseline aortic root diameter was 34·4 mm in the irbesartan group (SD 5·8) and placebo group (5·5). The mean rate of aortic root dilatation was 0·53 mm per year (95% CI 0·39 to 0·67) in the irbesartan group compared with 0·74 mm per year (0·60 to 0·89) in the placebo group, with a difference in means of -0·22 mm per year (-0·41 to -0·02, p=0·030). The rate of change in aortic Z score was also reduced by irbesartan (difference in means -0·10 per year, 95% CI -0·19 to -0·01, p=0·035). Irbesartan was well tolerated with no observed differences in rates of serious adverse events.

interpretationIrbesartan is associated with a reduction in the rate of aortic dilatation in children and young adults with Marfan syndrome and could reduce the incidence of aortic complications.

fundingBritish Heart Foundation, the UK Marfan Trust, the UK Marfan Association.

Indexed as

AdolescentAdultAngiotensin II Type 1 Receptor BlockersAortaChildDouble-Blind MethodDrug Administration ScheduleEchocardiographyFemaleHumansIrbesartanMaleMarfan SyndromeTreatment OutcomeUnited KingdomYoung AdultAngiotensin II Type 1 Receptor BlockersIrbesartan

Identifiers

PMID31836196
PMCPMC6934233
OpenAlexW2995392303

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.