Evidence map›Paper›PMID 36574590›Full record

ArticleArtificial organs2022

Postoperative tolvaptan use in left ventricular assist device patients: The TOLVAD randomized pilot study.

Mark N Belkin, Teruhiko Imamura, Daniel Rodgers, Anthony J Kanelidis, Michael P Henry, Takeo Fujino, Viktoriya Kagan, Karen Meehan, Justin Okray, Shana Creighton and 14 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Artificial organs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05408104 (Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 41% 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.

NCT05408104 completednot on this map

Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

TypeobservationalSponsorUniversity of ChicagoRan2019 to 2022Enrolled28ConditionsHeart Failure, Heart Assist Device, HyponatremicArmstolvaptan
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

24 authors at 4 institutions in 2 countries.

Mark N BelkinCardiology, UChicago Medicine, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0002-9489-4572
Teruhiko ImamuraSecond Department of Internal Medicine, University of Toyama, Toyama, Japan.ORCID https://orcid.org/0000-0002-7294-7637
Daniel RodgersCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Anthony J KanelidisCardiology, UChicago Medicine, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0002-7482-9888
Michael P HenryCardiology, UChicago Medicine, Chicago, Illinois, USA.
Takeo FujinoCardiology, Kyushu Daigaku, Fukuoka, Japan.
Viktoriya KaganCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Karen MeehanCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Justin OkrayCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Shana CreightonCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Colleen LaBuhnCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Tae SongCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Takeyoshi OtaCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Valluvan JeevanandamCardiac Surgery, UChicago Medicine, Chicago, Illinois, USA.
Ann B NguyenCardiology, UChicago Medicine, Chicago, Illinois, USA.
Ben B ChungCardiology, UChicago Medicine, Chicago, Illinois, USA.
Bryan A SmithCardiology, UChicago Medicine, Chicago, Illinois, USA.
Sara KalantariCardiology, UChicago Medicine, Chicago, Illinois, USA.
Jonathan GrinsteinCardiology, UChicago Medicine, Chicago, Illinois, USA.
Nitasha SarswatCardiology, UChicago Medicine, Chicago, Illinois, USA.
Sean P PinneyCardiology, UChicago Medicine, Chicago, Illinois, USA.
Gabriel SayerColumbia University Irving Medical Center, Weill Cornell Medicine, New York, New York, USA.
Gene KimCardiology, UChicago Medicine, Chicago, Illinois, USA.
Nir UrielColumbia University Irving Medical Center, Weill Cornell Medicine, New York, New York, USA.
University of Chicago · USCornell University · USKyushu University · JPUniversity of Toyama · JP

Funding

MULTIDISCIPLINARY CARDIAC SCIENCEST32HL007381 · NHLBI · UNIVERSITY OF CHICAGO · PI JEANNE M DECARA, Yoav Gilad · 1985 to 2026
$12.5M
NHLBI NIH HHS T32 HL007381
6 · The paper itself

Abstract

purposeTolvaptan, a selective vasopressin type-2 antagonist, has been shown to increase serum sodium (Na) and urine output in hyponatremic left ventricular assist device (LVAD) patients in retrospective studies. In this prospective randomized pilot study, we aimed to assess the efficacy of tolvaptan in this population.

methodsWe conducted a prospective, randomized, non-blinded pilot study of LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L) (NCT05408104). Eligible participants were randomized to receive tolvaptan 15 mg daily in addition to usual care versus usual care alone. The primary outcome was a change in Na level and estimated glomerular filtration rate (eGFR), from the first post-operative day of hyponatremia (the day of randomization) to discharge.

resultsA total of 33 participants were enrolled, and 28 underwent randomization (median age 55 [IQR 50-62]), 21% women, 54% Black, 32% ischemic cardiomyopathy, median baseline Na 135 (IQR 134-138). Fifteen participants were randomized to tolvaptan (TLV) and 13 were randomized to usual care alone (No-TLV). Mean change in Na from randomization to discharge in the TLV group was 2.7 mEq/L (95%CI 0.7-4.7, p = 0.013) and 1.8 (95%CI 0.5-4.0, p = 0.11) in the No-TLV group, though baseline and final Na levels were similar between groups. The mean change in eGFR was 2.6 ml/min/1.73 m

conclusionTLV significantly increases urine output, with nominal improvement in Na level, in hyponatremic post-operative LVAD patients without adversely impacting renal function.

Indexed as

diureticsheart failurehyponatremiaLVAD

Identifiers

PMID36574590
PMCPMC10227625
OpenAlexW4295942691

What OpenQuestion holds

Textmetadata
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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.