Evidence map›Paper›PMID 33639897›Full record

Trial reportBMC pulmonary medicine2021

Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial.

Asger Andersen, Farhad Waziri, Jacob Gammelgaard Schultz, Sarah Holmboe, Søren Warberg Becker, Tage Jensen, Hanne Maare Søndergaard, Karen Kaae Dodt, Ole May, Ulrik Markus Mortensen and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in BMC pulmonary medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04283240 (Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT04283240 early_phase1completednot on this map

Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism

TypeinterventionalSponsorUniversity of AarhusRan2015 to 2018Enrolled20ConditionsPulmonary EmbolismArmsSildenafil, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
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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

13 authors at 6 institutions in 1 country.

Asger AndersenDepartment of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark. asgerandersen@gmail.com.ORCID http://orcid.org/0000-0002-9102-3130
Farhad WaziriDepartment of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Jacob Gammelgaard SchultzDepartment of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Sarah HolmboeDepartment of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Søren Warberg BeckerDiagnostic Centre, Region Hospital of Silkeborg, Silkeborg, Denmark.
Tage JensenDepartment of Internal Medicine, Region Hospital of Randers, Randers, Denmark.
Hanne Maare SøndergaardDepartment of Cardiology, Region Hospital of Viborg, Viborg, Denmark.
Karen Kaae DodtDepartment of Internal Medicine, Region Hospital of Horsens, Horsens, Denmark.
Ole MayDepartment of Internal Medicine, Region Hospital of Herning, Herning, Denmark.
Ulrik Markus MortensenDepartment of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Won Yong KimDepartment of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Søren MellemkjærDepartment of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Jens Erik Nielsen-KudskDepartment of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Aarhus University Hospital · DKRegional Hospital Horsens · DKRegional Hospital Randers · DKRegionshospitalet Herning · DKRegionshospitalet Silkeborg · DKRegionshospitalet Viborg · DK

Funding

Novo Nordisk Fonden NNF16OC0023244
6 · The paper itself

Abstract

backgroundTo investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).

methodsSingle center, explorative trial. Patients with PE were randomized to a single oral dose of sildenafil 50 mg (n = 10) or placebo (n = 10) as add-on to conventional therapy. The time from hospital admission to study inclusion was 2.3 ± 0.7 days. Right ventricular function was evaluated immediately before and shortly after (0.5-1.5 h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR.

resultsPatients had acute intermediate-high risk PE verified by computed tomography pulmonary angiography, systolic blood pressure of 135 ± 18 (mean ± SD) mmHg, increased right ventricular/left ventricular ratio 1.1 ± 0.09 and increased troponin T 167 ± 144 ng/L. Sildenafil treatment did not improve cardiac index compared to baseline (0.02 ± 0.36 l/min/m2, p = 0.89) and neither did placebo (0.00 ± 0.34 l/min/m2, p = 0.97). Sildenafil lowered mean arterial blood pressure (- 19 ± 10 mmHg, p < 0.001) which was not observed in the placebo group (0 ± 9 mmHg, p = 0.97).

conclusionA single oral dose of sildenafil 50 mg did not improve cardiac index but lowered systemic blood pressure in patients with acute intermediate-high risk PE. The time from PE to intervention, a small patient sample size and low pulmonary vascular resistance are limitations of this study that should be considered when interpreting the results.

trial registrationThe trial was retrospectively registered at www.clinicaltrials.gov (NCT04283240) February 2nd 2020, https://clinicaltrials.gov/ct2/show/NCT04283240?term=NCT04283240&draw=2&rank=1 .

Indexed as

Administration, OralAgedAged, 80 and overArterial PressureCardiac CatheterizationEchocardiographyFemaleHeart VentriclesHumansMaleMiddle AgedPulmonary EmbolismSildenafil CitrateTreatment OutcomeVascular ResistanceVasodilationSildenafil CitratePDE5 inhibitionPulmonary embolismPulmonary vasodilationSildenafil

Identifiers

PMID33639897
PMCPMC7916297
OpenAlexW3134912550

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.