Evidence map›Paper›PMID 39878480›Full record

Trial reportFuture cardiology2025

Comparison of in-clinic assessment of 6MWT by conventional method and using wearable sensors for patients with ATTR-CM.

Prem Soman, Michel G Khouri, Daniel Lenihan, Alex Reyentovich, Brett W Sperry, Kristen Sowalsky, Yun Bai, Jing Du, Leonid Katz, Suresh Siddhanti and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Future cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03860935 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Cardiomyopathy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT03860935 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM Trial)

TypeinterventionalSponsorEidos Therapeutics, a BridgeBio companyRan2019 to 2023Enrolled632ConditionsAmyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, CardiomyopathiesArmsacoramidis, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

11 authors.

Prem SomanDivision of Cardiovascular Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Michel G KhouriDivision of Cardiology, Duke University School of Medicine, Durham, NC, USA.
Daniel LenihanSaint Francis Medical Center, Cape Girardeau, MO, USA.
Alex ReyentovichDepartment of Medicine, NYU Langone Medical Center, New York, NY, USA.
Brett W SperrySaint Luke's Mid America Heart Institute, Kansas City, MO, USA.
Kristen SowalskyAPDM Wearable Technologies, Portland, OR, USA.
Yun BaiBridgeBio Pharma, Inc., San Francisco, CA, USA.
Jing DuBridgeBio Pharma, Inc., San Francisco, CA, USA.
Leonid KatzBridgeBio Pharma, Inc., San Francisco, CA, USA.
Suresh SiddhantiBridgeBio Pharma, Inc., San Francisco, CA, USA.
Jonathan C FoxBridgeBio Pharma, Inc., San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 6-minute walk test (6MWT) is used to assess submaximal exercise capacity in clinical trials. Conducting the 6MWT can be challenging when patients cannot visit the clinic due to physical/travel limitations. This pilot study assessed the feasibility of conducting the 6MWT using wearable sensors for patients with transthyretin amyloid cardiomyopathy.

methodsParticipants were enrolled in the phase 3 ATTRibute-CM trial. Sensors were positioned on patients' feet and lower back during the 6MWT. The 6-minute walk distance (6MWD) was compared with the distance measured by a trained observer during a concurrent conventional test. Pearson and concordance correlation coefficients were estimated.

resultsTwelve participants from five centers participated; 11 had evaluable data. Mean 6MWD was 330.3 m (conventional method) and 335.1 m (wearable sensors); mean difference (SD) was 4.7 m (10.95). Pearson and concordance correlation coefficients for 6MWD were 0.998 (95% CI: 0.992-0.999) and 0.997 (95% CI: 0.991-0.999), respectively.

conclusionsThe 6MWD measured using wearable sensors and by the conventional method were closely correlated. Conducting the 6MWT with wearable sensors may be feasible and as reliable as the conventional method in a monitored clinic setting. Whether at-home 6MWD measured by wearable sensors correlates with in-clinic monitoring deserves further study. CLINICAL

trial registrationClinicalTrials.gov identifier is NCT03860935.

Indexed as

Amyloid Neuropathies, FamilialCardiomyopathiesExercise ToleranceWalk TestWearable Electronic DevicesAgedFeasibility StudiesFemaleHumansMaleMiddle AgedPilot Projects6-minute walk test6MWDATTR-CMexercise capacityheart failuretransthyretin amyloidosiswearable sensors

Identifiers

PMID39878480
PMCPMC11812369

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.