Evidence map›Paper›PMID 27716152›Full record

Trial reportBMC cardiovascular disorders2016

Rationale and design of the Children's Oncology Group (COG) study ALTE1621: a randomized, placebo-controlled trial to determine if low-dose carvedilol can prevent anthracycline-related left ventricular remodeling in childhood cancer survivors at high risk for developing heart failure.

Saro H Armenian, Melissa M Hudson, Ming Hui Chen, Steven D Colan, Lanie Lindenfeld, George Mills, Aida Siyahian, Sarah Gelehrter, Ha Dang, Wendy Hein and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC cardiovascular disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02717507 (Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT02717507 phase2completednot on this map

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial

TypeinterventionalSponsorChildren's Oncology GroupRan2016 to 2025Enrolled196ConditionsHematopoietic and Lymphoid Cell Neoplasm, Malignant Solid NeoplasmArmsCarvedilol, Laboratory Biomarker Analysis, Pharmacogenomic Study, Pharmacological Study, Placebo Administration
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Cardio-oncology for Pediatric and Adolescent/Young Adult Patients.Current treatment options in oncology · 2023
    Review
  10. Article
  11. Review
  12. Cardio-Oncology in Childhood: State of the Art.Current oncology reports · 2022
    Review
  13. Leveraging Clinical Trial Populations and Data from the Children's Oncology Group for Cancer Survivorship Research.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2022
    Article
  14. Article
  15. Current State of Pediatric Cardio-Oncology: A Review.Children (Basel, Switzerland) · 2022
    Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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

15 authors at 7 institutions in 1 country.

Saro H ArmenianDepartment of Population Sciences, City of Hope, 1500, East Duarte Road, Duarte, CA, 91010-3000, USA. sarmenian@coh.org.
Melissa M HudsonDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, USA.
Ming Hui ChenDepartment of Cardiology, Boston Children's Hospital, Boston, MA, USA.
Steven D ColanDepartment of Cardiology, Boston Children's Hospital, Boston, MA, USA.
Lanie LindenfeldDepartment of Population Sciences, City of Hope, 1500, East Duarte Road, Duarte, CA, 91010-3000, USA.
George MillsDepartment of Population Sciences, City of Hope, 1500, East Duarte Road, Duarte, CA, 91010-3000, USA.
Aida SiyahianDepartment of Population Sciences, City of Hope, 1500, East Duarte Road, Duarte, CA, 91010-3000, USA.
Sarah GelehrterPediatric Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.
Ha DangChildren's Oncology Group, Arcadia, CA, USA.
Wendy HeinSurvive & Thrive Long-term Follow-up Program, Children's Mercy Hospital, Kansas City, USA.
Daniel M GreenDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, USA.
Leslie L RobisonDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, USA.
F Lennie WongDepartment of Population Sciences, City of Hope, 1500, East Duarte Road, Duarte, CA, 91010-3000, USA.
Pamela S DouglasDivision of Cardiology, Department of Medicine, Durham, NC, USA.
Smita BhatiaInstitute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham, Birmingham, AL, USA.
City of Hope · USSt. Jude Children's Research Hospital · USBoston Children's Hospital · USArcadia · USChildren's Mercy Hospital · USC. S. Mott Children's Hospital · USUniversity of Alabama at Birmingham · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI XIWEI WU · 1985 to 2026
$86.3M
Towards a preventive cancer vaccine for children with constitutional mismatch repair deficiencyUG1CA189955 · NCI · PUBLIC HEALTH INSTITUTE · PI BRAD H POLLOCK, Michael E. Roth · 2014 to 2026
$62.5M
Oncology Research Career Development ProgramK12CA001727 · NCI · CITY OF HOPE NATIONAL MEDICAL CENTER · PI MORTIMER, JOANNE E. · 1992 to 2024
$14.6M
Reducing risk of Anthracycline-related heart failure after childhood cancerR01CA196854 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI ARMENIAN, SARO · 2015 to 2019
$3.2M
NCI NIH HHS K12 CA001727NCI NIH HHS P30 CA033572NCI NIH HHS R01 CA196854NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS UG1 CA189955
6 · The paper itself

Abstract

backgroundAnthracyclines are widely used in the treatment of childhood cancer. One of the well-recognized side-effects of anthracycline therapy is dose-dependent cardiomyopathy that may progress to heart failure (HF) years after completion of cancer-directed therapy. This study will evaluate the efficacy of low-dose beta-blocker (carvedilol) for HF risk reduction in childhood cancer survivors at highest risk for HF. The proposed intervention has the potential to significantly reduce chronic cardiac injury via interruption of neurohormonal systems responsible for left ventricular (LV) remodeling, resulting in improved cardiac function and decreased risk of HF. The intervention is informed by previous studies demonstrating efficacy in pediatric and adult non-oncology populations, yet remains unstudied in the pediatric oncology population. METHODS/

designThe primary objective of the trial is to determine impact of the intervention on echocardiographic markers of cardiac remodeling and HF risk, including: LV wall thickness/ dimension ratio (LVWT/D; primary endpoint), as well as LV ejection fraction, volume, and blood biomarkers (natriuretic peptides, galectin-3) associated with HF risk. Secondary objectives are to establish safety and tolerability of the 2-year course of carvedilol using: 1) objective measures: hepatic and cardiovascular toxicity, treatment adherence, and 2) subjective measures: participant self-reported outcomes. Two hundred and fifty survivors of childhood cancer (diagnosed <21 years of age), and previously treated with high-dose (≥300 mg/m DISCUSSION: When completed, this study will provide much-needed information regarding a physiologically plausible pharmacological risk-reduction strategy for childhood cancer survivors at high risk for developing anthracycline-related HF.

trial registrationClinicalTrials.gov; NCT02717507.

Indexed as

Adrenergic beta-AntagonistsAge FactorsAnthracyclinesAntibiotics, AntineoplasticCarbazolesCardiotoxicityCarvedilolClinical ProtocolsDouble-Blind MethodFemaleHeart FailureHumansHypertrophy, Left VentricularMalePropanolaminesResearch DesignAdrenergic beta-AntagonistsAnthracyclinesAntibiotics, AntineoplasticCarbazolesCarvedilolPropanolaminesAnthracyclinesCardiomyopathyCarvedilolChildhood cancerHeart failureRisk reductionSurvivors

Identifiers

PMID27716152
PMCPMC5050602
OpenAlexW2527696070

What OpenQuestion holds

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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.