Evidence map›Paper›PMID 30354576›Full record

Observational studyCirculation. Cardiovascular quality and outcomes2018

Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points.

Stephen J Greene, Adrian F Hernandez, Jie-Lena Sun, Javed Butler, Paul W Armstrong, Justin A Ezekowitz, Faiez Zannad, João Pedro Ferreira, Adrian Coles, Marco Metra and 4 more

Registry-linked trialAbstract readComparative StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Circulation. Cardiovascular quality and outcomes, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00475852 (Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT00475852 phase3completednot on this map

Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)

TypeinterventionalSponsorScios, Inc.Ran2007 to 2011Enrolled7,141ConditionsHeart DecompensationArmsNesiritide, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Neurohumoral Activation in Heart Failure.International journal of molecular sciences · 2023
    Review
  5. Article
  6. Application of the HEuropean journal of heart failure · 2019
    Article
  7. 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

14 authors.

Stephen J GreeneDuke Clinical Research Institute, Durham, NC (S.J.G., A.F.H., J.-L.S., A.C., R.M.C., C.M.O., R.J.M.).
Adrian F HernandezDuke Clinical Research Institute, Durham, NC (S.J.G., A.F.H., J.-L.S., A.C., R.M.C., C.M.O., R.J.M.).
Jie-Lena SunDuke Clinical Research Institute, Durham, NC (S.J.G., A.F.H., J.-L.S., A.C., R.M.C., C.M.O., R.J.M.).
Javed ButlerDepartment of Medicine, University of Mississippi Medical Center, Jackson (J.B.).
Paul W ArmstrongCanadian VIGOUR Centre, University of Alberta, Edmonton, Canada (P.W.A., J.A.E.).
Justin A EzekowitzCanadian VIGOUR Centre, University of Alberta, Edmonton, Canada (P.W.A., J.A.E.).
Faiez ZannadCentre d'Investigation Clinique Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, France (F.Z., J.P.F.).
João Pedro FerreiraCentre d'Investigation Clinique Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, France (F.Z., J.P.F.).
Adrian ColesDuke Clinical Research Institute, Durham, NC (S.J.G., A.F.H., J.-L.S., A.C., R.M.C., C.M.O., R.J.M.).
Marco MetraCardiology, University of Brescia, Italy (M.M.).
Adriaan A VoorsUniversity of Groningen, the Netherlands (A.A.V.).
Robert M CaliffDuke Clinical Research Institute, Durham, NC (S.J.G., A.F.H., J.-L.S., A.C., R.M.C., C.M.O., R.J.M.).
Christopher M O'ConnorDuke Clinical Research Institute, Durham, NC (S.J.G., A.F.H., J.-L.S., A.C., R.M.C., C.M.O., R.J.M.).
Robert J MentzDuke Clinical Research Institute, Durham, NC (S.J.G., A.F.H., J.-L.S., A.C., R.M.C., C.M.O., R.J.M.).

Funding

Tracking and Evaluation CoreU54GM115428 · NIGMS · UNIVERSITY OF MISSISSIPPI MED CTR · PI HALL, JOHN E · 2016 to 2025
$38.2M
TRANSFORM-HF CCCU01HL125511 · NHLBI · YALE UNIVERSITY · PI MENTZ, ROBERT JOHN, VELAZQUEZ, ERIC J · 2017 to 2021
$7.7M
REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure PatientsR01AG045551 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI KITZMAN, DALANE W · 2014 to 2018
$6.8M
Postdoctoral Training in Cardiovascular Clinical ResearchT32HL069749 · NHLBI · DUKE UNIVERSITY · PI MARK, DANIEL B · 2003 to 2023
$6.7M
Heart Failure Clinical Research Network Regional Clinical Center (U10)U10HL110312 · NHLBI · DUKE UNIVERSITY · PI FELKER, GARY M · 2012 to 2018
$3.5M
NHLBI NIH HHS T32 HL069749NHLBI NIH HHS U01 HL125511NHLBI NIH HHS U10 HL110312NIA NIH HHS R01 AG045551NIGMS NIH HHS U54 GM115428
6 · The paper itself

Abstract

backgroundGlobalization of clinical trials fosters inclusion of higher and lower income countries, but the influence of enrolling country income level on heart failure trial performance is unclear. This study sought to evaluate associations between enrolling country income level, acute heart failure patient profile, protocol completion, and trial end points. METHODS AND

resultsThe ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial included 7141 patients with acute heart failure from 30 countries. Country income data in gross national income per capita in current US dollars from the year 2007 (ie, the year trial enrollment began) were abstracted from the World Bank. Patients were grouped by enrolling country income level (ie, high [>$11 455], upper middle [$3706-$11 455], lower middle [$936-$3705], and low [<$936]). Income data were available for 29 (97%) countries (N=7064). There were 3996 (57%), 1518 (21%), and 1550 (22%) patients from high-income, upper-middle-income, and lower-middle-income countries, respectively. There were no patients from low-income countries. Patients from lower-middle-income countries tended to be younger with fewer comorbidities and lower utilization of guideline-directed therapies. Rates of adverse events (13.8%) and protocol noncompletion (4.9%) during 180-day follow-up were highest among high-income countries (all P <0.01). After adjustment for race, geographic region, and clinical characteristics, compared with lower-middle-income countries, enrollment from higher income countries was associated with increased 30-day mortality or rehospitalization (high income: odds ratio, 1.70; 95% CI, 1.02-2.85; upper-middle-income: odds ratio, 2.16; 95% CI, 1.23-3.81), driven by higher rates of rehospitalization. Mortality was similar at 30 and 180 days. The association between higher country income and the 30-day composite end point was similar across geographic regions, with exception of Latin America ( P for interaction, 0.03).

conclusionsIn this global acute heart failure trial, patients from higher income countries had lower rates of protocol completion, higher rates of adverse events, and similar mortality rates. After adjustment for race, geographic region, and clinical factors, enrollment from a higher income country was associated with worse clinical outcomes, driven by higher rates of rehospitalization. Variation in enrolling country income level may influence study end points and trial performance independent of geographic region. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov . Unique identifier: NCT00475852.

Indexed as

Endpoint DeterminationIncomePatient SelectionResearch SubjectsSocial Determinants of HealthAgedDatabases, FactualFemaleHealthcare DisparitiesHealth Status DisparitiesHeart FailureHumansMaleMiddle AgedMulticenter Studies as TopicNatriuretic AgentsNatriuretic AgentsNatriuretic Peptide, Brainclinical trialheart failurehospitalizationincome

Identifiers

PMID30354576
PMCPMC6208149

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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.