Evidence map›Paper›PMID 24289736›Full record

Trial reportTrials2013

A prospective, randomized, placebo-controlled, double-blind, multicenter study of the effects of irbesartan on aortic dilatation in Marfan syndrome (AIMS trial): study protocol.

Michael J Mullen, Marcus D Flather, Xu Yu Jin, William G Newman, Guliz Erdem, David Gaze, Oswaldo Valencia, Winston Banya, Claire E Foley, Anne Child

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Beta-blockers for preventing aortic dissection in Marfan syndrome.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. A review of thoracic aortic aneurysm disease.Echo research and practice · 2020
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
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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

10 authors at 6 institutions in 1 country.

Michael J MullenThe Heart Hospital, University College London Hospitals NHS Foundation Trust, 16-18 Westmoreland Street, London W1G 8PH, UK. michael.mullen@uclh.nhs.uk.
Marcus D Flather
Xu Yu Jin
William G Newman
Guliz Erdem
David Gaze
Oswaldo Valencia
Winston Banya
Claire E Foley
Anne Child
St George's, University of London · GBRoyal Brompton & Harefield NHS Foundation Trust · GBJohn Radcliffe Hospital · GBRoyal Brompton Hospital · GBSt Mary's Hospital · GBUniversity of East Anglia · GB

Funding

British Heart Foundation SP/09/006/25108
6 · The paper itself

Abstract

backgroundCardiovascular complications are the leading cause of mortality and morbidity in Marfan syndrome (MFS), a dominantly inherited disorder caused by mutations in the gene that encodes fibrillin-1. There are approximately 18,000 patients in the UK with MFS. Current treatment includes careful follow-up, beta blockers, and prophylactic surgical intervention; however, there is no known treatment which effectively prevents the rate of aortic dilatation in MFS. Preclinical, neonatal, and pediatric studies have indicated that angiotensin receptor blockers (ARBs) may reduce the rate of aortic dilatation. This trial will investigate the effects of irbesartan on aortic dilatation in Marfan syndrome. METHODS/

designThe Aortic Irbesartan Marfan Study (AIMS) is an investigator-led, prospective, randomized, placebo-controlled, double-blind, phase III, multicenter trial. Currently, 26 centers in the UK will recruit 490 clinically confirmed MFS patients (aged ≥6 to ≤40 years) using the revised Ghent diagnostic criteria. Patients will be randomized to irbesartan or placebo. Aortic root dilatation will be measured by transthoracic echocardiography at baseline and annually thereafter. The primary outcome is the absolute change in aortic root diameter per year measured by echocardiography. The follow-up period will be a minimum of 36 months with an expected mean follow-up period of 48 months. DISCUSSION: This is the first clinical trial to evaluate the ARB irbesartan versus placebo in reducing the rate of aortic root dilatation in MFS. Not only will this provide useful information on the safety and efficacy of ARBs in MFS, it will also provide a rationale basis for potentially lifesaving therapy for MFS patients.

trial registrationISRCTN, 90011794.

Indexed as

Research DesignAdolescentAdultAngiotensin II Type 1 Receptor BlockersAortaAortic AneurysmBiphenyl CompoundsChildClinical ProtocolsDilatation, PathologicDouble-Blind MethodHumansIrbesartanMarfan SyndromeProspective StudiesTetrazolesAngiotensin II Type 1 Receptor BlockersBiphenyl CompoundsIrbesartanTetrazoles

Identifiers

PMID24289736
PMCPMC4220813
OpenAlexW2141814689

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.