Evidence map›Paper›PMID 21527519›Full record

Trial reportBlood2011

Hospitalization for pain in patients with sickle cell disease treated with sildenafil for elevated TRV and low exercise capacity.

Roberto F Machado, Robyn J Barst, Nancy A Yovetich, Kathryn L Hassell, Gregory J Kato, Victor R Gordeuk, J Simon R Gibbs, Jane A Little, Dean E Schraufnagel, Lakshmanan Krishnamurti and 13 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 132 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
132citing papers in PubMed, 3 pooled it
9.6field-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.

NCT00492531 phase2terminatednot on this map

Treatment of Pulmonary Hypertension and Sickle Cell Disease With Sildenafil Therapy

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2007 to 2009Enrolled74ConditionsSickle Cell Disease, Pulmonary HypertensionArmsSildenafil, Placebo
NCT02651272 phase2terminatednot on this mapstarted 2015, after this paper: background citation

The Safety and Efficacy of Macitentan for Treatment of Pulmonary Hypertension in Sickle Cell Disease

TypeinterventionalSponsorBoston UniversityRan2015 to 2019Enrolled4ConditionsPulmonary Hypertension, Sickle Cell DiseaseArmsmacitentan
NCT02824471 recruitingnot on this mapstarted 2014, after this paper: background citation

Sickle Cell Disease (SCD) Biochip': Towards a Simple and Reliable Way to Monitor Sickle Cell Disease

TypeobservationalSponsorUniversity Hospitals Cleveland Medical CenterRan2014 to 2028Enrolled100ConditionsSickle Cell DiseaseArmsSCD Group
3 · Its place in the literature

Who cites it

132 citing papers in PubMed, 3 syntheses or guidelines pooled it, 246 citations in OpenAlex.

  1. Pooled it
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  5. The CYB5R3American journal of hematology · 2020
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72 more citing papers are in PubMed but not listed here.

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

23 authors at 12 institutions in 2 countries.

Roberto F MachadoUniversity of Illinois, Chicago, IL, USA.
Robyn J Barst
Nancy A Yovetich
Kathryn L Hassell
Gregory J Kato
Victor R Gordeuk
J Simon R Gibbs
Jane A Little
Dean E Schraufnagel
Lakshmanan Krishnamurti
Reda E Girgis
Claudia R Morris
Erika B Rosenzweig
David B Badesch
Sophie Lanzkron
Onyinye Onyekwere
Oswaldo L Castro
Vandana Sachdev
Myron A Waclawiw
Rob Woolson
Jonathan C Goldsmith
Mark T Gladwin
walk-PHaSST Investigators and Patients
Howard University · USColumbia University · USJohns Hopkins University · USNational Heart Lung and Blood Institute · USRho (United States) · USUniversity of Colorado Denver · USUniversity of Illinois Chicago · USAlbert Einstein College of Medicine · USCancer Research And Biostatistics · USChildren's Hospital of Pittsburgh · USImperial College London · GBUniversity of Pittsburgh · US

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
Treatment of PH and SCD with Sildenafil TherapyZIAHL005116 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI KATO, GREGORY · 2009 to 2012
$1.4M
Sickle Cell Disease: First steps toward understanding barriers to care for adultsK23HL083089 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI LANZKRON, SOPHIE M · 2008 to 2012
$701k
Intramural NIH HHS ZIA HL005116NCRR NIH HHS UL1 RR024131NHLBI NIH HHS K23HL083089-03
6 · The paper itself

Abstract

In adults with sickle cell disease (SCD), an increased tricuspid regurgitation velocity (TRV) by Doppler echocardiography is associated with increased morbidity and mortality. Although sildenafil has been shown to improve exercise capacity in patients with pulmonary arterial hypertension, it has not been evaluated in SCD. We therefore sought to determine whether sildenafil could improve exercise capacity in SCD patients with increased TRV and a low exercise capacity. A TRV ≥ 2.7 m/s and a 6-minute walk distance (6MWD) between 150 and 500 m were required for enrollment in this 16-week, double-blind, placebo-controlled sildenafil trial. After 74 of the screened subjects were randomized, the study was stopped early due to a higher percentage of subjects experiencing serious adverse events in the sildenafil arm (45% of sildenafil, 22% of placebo, P = .022). Subject hospitalization for pain was the predominant cause for this difference: 35% with sildenafil compared with 14% with placebo (P = .029). There was no evidence of a treatment effect on 6MWD (placebo-corrected effect -9 m; 95% confidence interval [95% CI] -56-38; P = .703), TRV (P = .503), or N-terminal pro-brain natriuretic peptide (P = .410). Sildenafil appeared to increase hospitalization rates for pain in patients with SCD. This study is registered at www.clinicaltrials.gov as NCT00492531.

Indexed as

Anemia, Sickle CellDouble-Blind MethodExercise ToleranceFemaleHemodynamicsHospitalizationHumansMaleMiddle AgedPainPiperazinesPurinesSildenafil CitrateSulfonesTricuspid Valve InsufficiencyVasodilator AgentsPiperazinesPurinesSildenafil CitrateSulfonesVasodilator Agents

Identifiers

PMID21527519
PMCPMC3148167
OpenAlexW2058021592

What OpenQuestion holds

Textmetadata
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.