Trial reportNature medicine2022

The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial.

John A Spertus, Mary C Birmingham, Michael Nassif, C V Damaraju, Antonio Abbate, Javed Butler, David E Lanfear, Ildiko Lingvay, Mikhail N Kosiborod, James L Januzzi

2 registry-linked trialsOpen access · hybridFull text readRandomized Controlled Trial
In one paragraph

Trial report in Nature medicine, 2022. The graph read 1 number from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. It reports registered trial NCT04252287. Cited by 142 papers, 18 of them syntheses that pooled it.

1number the graph read from it
0cells of the map it votes in
142citing papers in PubMed, 18 pooled it
30.8field-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.

Read, but not usablea number the graph found but could not read as for or against

Cardiac & vascular functiondirection of benefit for this outcome is not defined · against placebo · heart_failure, ascvdfeeds one cell of the map
change 4.300.80 to 7.80P = 0.016
The 12-week change in KCCQ TSS was 4.3 points (95% confidence interval, 0.8-7.8; P = 0.016) higher with canagliflozin than with placebo, meeting the primary endpoint.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

SGLT2 inhibitors×cardiac & vascular function

No readable resultOpen on the map →What to test next →

12 readable studies in this cell: 6 favour the treatment, 6 find no difference, 0 favour the comparator.

Belief with this paper
0.50contested · 6 families support, 3 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
This paper’s trial, registry resultNCT04252287 · 476 enrolled · 2020
Δ 4.300.80 to 7.80
NCT030579515,988 enrolled · 2017
Δ 1.320.45 to 2.19
NCT030579773,730 enrolled · 2017
Δ 2.060.16 to 3.96
NCT03448406315 enrolled · 2018
Δ 4.00-5.00 to 13.0
NCT03448419312 enrolled · 2018
Δ -4.00-16.0 to 6.00
NCT0297347745 enrolled · 2017
Coefficient 0.01-0.23 to 0.25
4 · 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
NCT06142474 phase3recruiting

The Potential Beneficial Effects of SGLT2 Inhibitors in Patients With Acute Decompensated Heart Failure During Ventilator Weaning: a Prospective Multicenter Cohort Study.

Ran2022Enrolled450Registered outcomes7Posted comparisons0ConditionsHeart Failure Acute, Ventilator LungArmsSGLT2 inhibitor
Open the trial in the graph
5 · Its place in the literature

Who cites it

142 citing papers in PubMed, 18 syntheses or guidelines pooled it, 228 citations in OpenAlex.

  1. Guideline
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  9. Dapagliflozin in Heart Failure: A Comprehensive Meta-analysis on Functional Capacity, Symptoms, and Safety Outcomes.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024
    Pooled it
  10. Pooled it
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  19. Trial
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82 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

10 authors at 8 institutions in 1 country.

John A SpertusSaint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, MO, USA. spertusj@umkc.edu.ORCID http://orcid.org/0000-0002-2839-2611
Mary C BirminghamJanssen Scientific Affairs, LLC, Titusville, NJ, USA.ORCID http://orcid.org/0000-0002-5803-8410
Michael NassifSaint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, MO, USA.
C V DamarajuJanssen Research & Development, LLC, Raritan, NJ, USA.ORCID http://orcid.org/0000-0003-4925-4987
Antonio AbbateWright Center for Clinical and Translation Research and Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, USA.ORCID http://orcid.org/0000-0002-1930-785X
Javed ButlerUniversity of Mississippi Medical Center, Jackson, MS, USA.
David E LanfearHenry Ford Health System, Detroit, MI, USA.ORCID http://orcid.org/0000-0001-6471-1483
Ildiko LingvayUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.ORCID http://orcid.org/0000-0001-7006-7401
Mikhail N Kosiborod *Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, MO, USA.ORCID http://orcid.org/0000-0002-3750-9789
James L Januzzi *Massachusetts General Hospital, Harvard Medical School and Baim Institute for Clinical Research, Boston, MA, USA.ORCID http://orcid.org/0000-0002-8338-1798
Janssen (United States) · USSaint Luke's Hospital · USHarvard University · USHenry Ford Health System · USJackson Memorial Hospital · USSaint Luke's Health System · USThe University of Texas Southwestern Medical Center · USVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

Large traditional clinical trials suggest that sodium-glucose co-transporter 2 inhibitors improve symptoms in patients with heart failure and reduced ejection fraction (HFrEF) and in patients with heart failure and preserved ejection fraction (HFpEF). In the midst of the Coronavirus Disease 2019 pandemic, we sought to confirm these benefits in a new type of trial that was patient centered and conducted in a completely remote fashion. In the CHIEF-HF trial ( NCT04252287 ), 476 participants with HF, regardless of EF or diabetes status, were randomized to 100 mg of canagliflozin or placebo. Enrollment was stopped early due to shifting sponsor priorities, without unblinding. The primary outcome was change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at 12 weeks. The 12-week change in KCCQ TSS was 4.3 points (95% confidence interval, 0.8-7.8; P = 0.016) higher with canagliflozin than with placebo, meeting the primary endpoint. Similar effects were observed in participants with HFpEF and in those with HFrEF and in participants with and without diabetes, demonstrating that canagliflozin significantly improves symptom burden in HF, regardless of EF or diabetes status. This randomized, double-blind trial, conducted without in-person interactions between doctor and patient, can serve as a model for future all-virtual clinical trials.

Indexed as

COVID-19Heart FailureSodium-Glucose Transporter 2 InhibitorsVentricular Dysfunction, LeftCanagliflozinHumansPatient-Centered CareQuality of LifeStroke VolumeCanagliflozinSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID35228753
PMCPMC9018422
OpenAlexW4214512384

What OpenQuestion holds

Textfull text, public
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.