Evidence map›Paper›PMID 25935877›Full record

Trial reportEuropean heart journal2015

Marfan Sartan: a randomized, double-blind, placebo-controlled trial.

Olivier Milleron, Florence Arnoult, Jacques Ropers, Philippe Aegerter, Delphine Detaint, Gabriel Delorme, David Attias, Florence Tubach, Sophie Dupuis-Girod, Henry Plauchu and 15 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European heart journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00763893 (Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome), which is not on this map. Cited by 83 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 7 pooled it
21.8field-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.

NCT00763893 phase3terminatednot on this map

Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2008 to 2014Enrolled303ConditionsMarfan SyndromeArmsplacebo, Losartan
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 7 syntheses or guidelines pooled it, 209 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Guideline
  4. Guideline
  5. Pooled it
  6. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019).Hypertension research : official journal of the Japanese Society of Hypertension · 2019
    Guideline
  7. Beta-blockers for preventing aortic dissection in Marfan syndrome.The Cochrane database of systematic reviews · 2017
    Pooled it
  8. Trial
  9. Trial
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  11. Trial
  12. Review
  13. Article
  14. Article
  15. Article
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  17. Review
  18. Review
  19. Use of iPSC-Derived Smooth Muscle Cells to Model Physiology and Pathology.Arteriosclerosis, thrombosis, and vascular biology · 2024
    Review
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 12 institutions in 1 country.

Olivier MilleronCentre National de Référence pour le syndrome de Marfan et apparentés, Hôpital Bichat, 46 rue Henry Huchard, Paris 75018, France Service de Cardiologie, AP-HP, Hôpital Bichat, Paris, France.
Florence ArnoultCentre National de Référence pour le syndrome de Marfan et apparentés, Hôpital Bichat, 46 rue Henry Huchard, Paris 75018, France Service d'explorations fonctionnelles, AP-HP, Hôpital Bichat, Paris, France.
Jacques RopersUnité de Recherche Clinique HU Paris Île-de-France Ouest, AP-HP, Hôpital Ambroise Paré, Boulogne, France.
Philippe AegerterUnité de Recherche Clinique HU Paris Île-de-France Ouest, AP-HP, Hôpital Ambroise Paré, Boulogne, France Université Versailles St-Quentin, Paris EA2506, France.
Delphine DetaintCentre National de Référence pour le syndrome de Marfan et apparentés, Hôpital Bichat, 46 rue Henry Huchard, Paris 75018, France Service de Cardiologie, AP-HP, Hôpital Bichat, Paris, France.
Gabriel DelormeCentre National de Référence pour le syndrome de Marfan et apparentés, Hôpital Bichat, 46 rue Henry Huchard, Paris 75018, France.
David AttiasCentre National de Référence pour le syndrome de Marfan et apparentés, Hôpital Bichat, 46 rue Henry Huchard, Paris 75018, France.
Florence TubachAP-HP, Hôpital Bichat, Biostatistique et Recherche Clinique, Paris, France INSERM, Paris U738, France Université Denis Diderot Paris VII, 75013 Paris, France.
Sophie Dupuis-GirodService de Génétique, Hôpital Hôtel-Dieu, Lyon, France.
Henry PlauchuService de Génétique, Hôpital Hôtel-Dieu, Lyon, France.
Martine BartheletService de Cardiologie, Lyon, France.
Francois SassolasService de Cardiologie, Lyon, France.
Nicolas PangaudService de Cardiologie, Lyon, France.
Sophie NaudionService de Génétique, CHU Bordeaux, Bordeaux, France.
Julie Thomas-ChabaneixService des Maladies Cardio-vasculaires Congénitales, CHU Bordeaux, Bordeaux, France.
Yves DulacCHU Toulouse, Toulouse, France.
Thomas EdouardCHU Toulouse, Toulouse, France.
Jean-Eric WolfCHU Dijon, Dijon, France.
Laurence FaivreCHU Dijon, Dijon, France.
Sylvie OdentService de Génétique Clinique, CHU Hôpital sud, Université de Rennes 1, Rennes, France.
Adeline Basquinservice de Cardiologie, CHU Hôpital Pontchaillou, Rennes, France.
Gilbert HabibCHU Marseille, Marseille, France.
Patrick CollignonCHU Marseille, Marseille, France.
Catherine BoileauCentre National de Référence pour le syndrome de Marfan et apparentés, Hôpital Bichat, 46 rue Henry Huchard, Paris 75018, France Université Denis Diderot Paris VII, 75013 Paris, France INSERM LVTS U1148, Paris 75018, France Département de Génétique, AP-HP, Hôpital Bichat, Paris, France.
Guillaume JondeauCentre National de Référence pour le syndrome de Marfan et apparentés, Hôpital Bichat, 46 rue Henry Huchard, Paris 75018, France Service de Cardiologie, AP-HP, Hôpital Bichat, Paris, France INSERM LVTS U1148, Paris 75018, France guillaume.jondeau@bch.aphp.fr.
Hôpital Bichat-Claude-Bernard · FRSociété Française de Cardiologie · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Toulouse · FRCentre Hospitalier Universitaire Dijon Bourgogne · FRHôpital Ambroise-Paré · FRHôtel-Dieu de Lyon · FRCentre Hospitalier Universitaire de Bordeaux · FRHôpital Pontchaillou · FRInserm · FRUniversité de Rennes · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo evaluate the benefit of adding Losartan to baseline therapy in patients with Marfan syndrome (MFS). METHODS AND

resultsA double-blind, randomized, multi-centre, placebo-controlled, add on trial comparing Losartan (50 mg when <50 kg, 100 mg otherwise) vs. placebo in patients with MFS according to Ghent criteria, age >10 years old, and receiving standard therapy. 303 patients, mean age 29.9 years old, were randomized. The two groups were similar at baseline, 86% receiving β-blocker therapy. The median follow-up was 3.5 years. The evolution of aortic diameter at the level of the sinuses of Valsalva was not modified by the adjunction of Losartan, with a mean increase in aortic diameter at the level of the sinuses of Valsalva of 0.44 mm/year (s.e. = 0.07) (-0.043 z/year, s.e. = 0.04) in patients receiving Losartan and 0.51 mm/year (s.e. = 0.06) (-0.01 z/year, s.e. = 0.03) in those receiving placebo (P = 0.36 for the comparison on slopes in millimeter per year and P = 0.69 for the comparison on slopes on z-scores). Patients receiving Losartan had a slight but significant decrease in systolic and diastolic blood pressure throughout the study (5 mmHg). During the study period, aortic surgery was performed in 28 patients (15 Losartan, 13 placebo), death occurred in 3 patients [0 Losartan, 3 placebo, sudden death (1) suicide (1) oesophagus cancer (1)].

conclusionLosartan was able to decrease blood pressure in patients with MFS but not to limit aortic dilatation during a 3-year period in patients >10 years old. β-Blocker therapy alone should therefore remain the standard first line therapy in these patients.

Indexed as

AdolescentAdrenergic beta-AntagonistsAdultAgedAngiotensin II Type 1 Receptor BlockersAortic DiseasesBlood PressureDilatation, PathologicDouble-Blind MethodDrug Administration ScheduleFemaleHeart RateHumansHypertensionLosartanMaleAdrenergic beta-AntagonistsAngiotensin II Type 1 Receptor BlockersLosartanAortaEchocardiographyMarfanSartan

Identifiers

PMID25935877
OpenAlexW2113779039

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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.