Evidence map›Paper›PMID 32302009›Full record

Trial reportBritish journal of clinical pharmacology2020

Randomized study of the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval in healthy subjects.

Christian Funck-Brentano, Mathieu Felices, Nathalie Le Fur, Corinne Dubourdieu, Pierre Desché, Frédéric Vanhoutte, Pascal Voiriot

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Review
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

7 authors.

Christian Funck-BrentanoINSERM, CIC-1901 and UMRS 1166, Paris, France; AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology and CIC-1901, Paris, France; Sorbonne Université Médecine, Paris, France; Institute of Cardiometabolism and Nutrition (ICAN), Paris, France.ORCID 0000-0003-0406-5189
Mathieu FelicesPhinc, Massy, France.
Nathalie Le FurGuerbet, Roissy CDG Cedex, France.ORCID 0000-0001-5078-3494
Corinne DubourdieuGuerbet, Roissy CDG Cedex, France.
Pierre DeschéGuerbet, Roissy CDG Cedex, France.ORCID 0000-0002-2389-0697
Frédéric VanhoutteSGS Clinical Pharmacology Unit, ZNA Stuivenberg, Antwerp, Belgium.
Pascal VoiriotCardiabase, Nancy, France.

Funding

Guerbet
6 · The paper itself

Abstract

aimsWe investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product.

methodsThis was a single centre, randomized, double-blind, placebo- and positive-controlled, 4-way crossover study. Forty-eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg

resultsThe largest time-matched placebo-corrected, mean change from-baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg

conclusionThis thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia.

Indexed as

GadoliniumLong QT SyndromeAzabicyclo CompoundsContrast MediaCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodElectrocardiographyFemaleFluoroquinolonesHealthy VolunteersHeart RateHumansMaleAzabicyclo CompoundsContrast MediaFluoroquinolonesGadoliniumgadopiclenolgadopiclenolhealthy subjectsosmolarityQTc intervalthorough QT study

Identifiers

PMID32302009
PMCPMC7576613

What Socratic holds

Textmetadata
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 Socratic graph.