Evidence map›Paper›PMID 33724883›Full record

ArticleCirculation. Heart failure2021

Novel Trial Design: CHIEF-HF.

John A Spertus, Mary C Birmingham, Javed Butler, Ildiko Lingvay, David E Lanfear, Antonio Abbate, Mikhail L Kosiborod, Christina Fawcett, Paul Burton, C V Damaraju and 2 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial Protocol
In one paragraph

Article in Circulation. Heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT04252287. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT04252287 phase3completed

Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure

Ran2020Enrolled476Registered outcomes5Posted comparisons2ConditionsHeart FailureArmsCanagliflozin 100 mg, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
  5. Review
  6. Review
  7. Article
  8. Decentralized Clinical Trials in Oncology: Are We Ready for a Virtual-First Paradigm?Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Overview of trials from AHA 2021.Global cardiology science & practice · 2021
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 1 country.

John A SpertusSaint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.S., M.K.).
Mary C BirminghamJanssen Scientific Affairs, LLC Titusville, NJ (M.B.,J.W.).
Javed ButlerUniversity of Mississippi Oxford (J.B.).
Ildiko LingvayUniversity of Texas Southwestern Medical Center, Dallas, TX (I.L.).
David E LanfearHenry Ford Hospital Detroit, MI (D.E.L.).
Antonio AbbateVirginia Commonwealth University Richmond (A.A.).
Mikhail L KosiborodSaint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.S., M.K.).
Christina FawcettPRA Health Sciences Raritan, NJ (C.F.).
Paul BurtonJanssen Research & Development, LLC Titusville, NJ (C.V.D., P.B.).
C V DamarajuJanssen Research & Development, LLC Titusville, NJ (C.V.D., P.B.).
James L JanuzziMassachusetts General Hospital Boston (J.J.).
John WhangJanssen Scientific Affairs, LLC Titusville, NJ (M.B.,J.W.).
Janssen (United States) · USSaint Luke's Health System · USHenry Ford Hospital · USMassachusetts General Hospital · USThe University of Texas Southwestern Medical Center · USTwitter (United States) · USUniversity of Mississippi · USVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe expense of clinical trials mandates new strategies to efficiently generate evidence and test novel therapies. In this context, we designed a decentralized, patient-centered randomized clinical trial leveraging mobile technologies, rather than in-person site visits, to test the efficacy of 12 weeks of canagliflozin for the treatment of heart failure, regardless of ejection fraction or diabetes status, on the reduction of heart failure symptoms.

methodsOne thousand nine hundred patients will be enrolled with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction and randomized 1:1 to 100 mg daily of canagliflozin or matching placebo. The primary outcome will be the 12-week change in the total symptom score of the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes will be daily step count and other scales of the Kansas City Cardiomyopathy Questionnaire.

resultsThe trial is currently enrolling, even in the era of the coronavirus disease 2019 (COVID-19) pandemic.

conclusionsCHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) is deploying a novel model of conducting a decentralized, patient-centered, randomized clinical trial for a new indication for canagliflozin to improve the symptoms of patients with heart failure. It can model a new method for more cost-effectively testing the efficacy of treatments using mobile technologies with patient-reported outcomes as the primary clinical end point of the trial. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04252287.

Indexed as

TelemedicineActigraphyCanagliflozinDouble-Blind MethodExercise ToleranceFitness TrackersHeart FailureHumansMobile ApplicationsQuality of LifeRandomized Controlled Trials as TopicRecovery of FunctionSodium-Glucose Transporter 2 InhibitorsStroke VolumeTime FactorsTreatment OutcomeCanagliflozinSodium-Glucose Transporter 2 InhibitorscanagliflozincardiomyopathyCOVID-19heart failureKansas City Cardiomyopathy Questionnaire

Identifiers

PMID33724883
PMCPMC7982129
OpenAlexW3136910691

What OpenQuestion holds

Texttitle and abstract
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.