Evidence map›Paper›PMID 36718638›Full record

ArticleFuture cardiology2023

Plain Language Summary of Publication of the safety and efficacy of ARRY-371797 in people with dilated cardiomyopathy and a faulty

Calum A MacRae, Matthew Rg Taylor, Luisa Mestroni, John Moses, Euan A Ashley, Matthew T Wheeler, Neal K Lakdawala, Ray E Hershberger, Victor Sandor, Michael E Saunders and 3 more

3 registry-linked trialsOpen access · hybridAbstract readCommentPatient Education Handout
PubMed Publisher
In one paragraph

Article in Future cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are 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
0.7field-weighted citation impact, top 30% 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.

NCT02057341 phase2completednot on this map

A Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy

TypeinterventionalSponsorPfizerRan2014 to 2016Enrolled12ConditionsLMNA-Related Dilated CardiomyopathyArmsARRY-371797, p38 inhibitor, oral
NCT02351856 phase2completednot on this map

An Open-label Rollover Study of ARRY-371797 in Patients With Symptomatic Genetic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

TypeinterventionalSponsorPfizerRan2015 to 2020Enrolled8ConditionsLMNA-Related Dilated CardiomyopathyArmsARRY-371797, p38 inhibitor, oral
NCT03439514 phase3terminatednot on this map

A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation (REALM-DCM)

TypeinterventionalSponsorPfizerRan2018 to 2022Enrolled77ConditionsDilated Cardiomyopathy, Lamin A/C Gene MutationArmsARRY-371797 (PF-07265803), Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 1 country.

Calum A MacRaeBrigham & Women's Hospital, Cardiovascular Medicine, Boston, MA, USA.
Matthew Rg TaylorUniversity of Colorado, Department of Medicine, Adult Medical Genetics Program, Aurora, CO, USA.
Luisa MestroniUnityPoint Health, Heart & Vascular Institute, Madison, WI, USA.
John MosesUnityPoint Health, Heart & Vascular Institute, Madison, WI, USA.
Euan A AshleyStanford University, Center for Inherited Cardiovascular Disease, Stanford, CA, USA.
Matthew T WheelerStanford University, Center for Inherited Cardiovascular Disease, Stanford, CA, USA.
Neal K LakdawalaBrigham & Women's Hospital, Cardiovascular Medicine, Boston, MA, USA.
Ray E HershbergerThe Ohio State University, Human Genetics & Cardiovascular Medicine, Columbus, OH, USA.
Victor SandorPfizer Inc, Boulder, CO, USA.
Michael E SaundersPfizer Inc, Boulder, CO, USA.
Colleen OliverPfizer Inc, Boulder, CO, USA.
Patrice A LeePfizer Inc, Boulder, CO, USA.
Daniel P JudgeMedical University of South Carolina, Cardiovascular Genetics, Charleston, SC, USA.
Pfizer (United States) · USBrigham and Women's Hospital · USUnityPoint Health · USCardiovascular Institute of the South · USMedical University of South Carolina · USStanford University · USThe Ohio State University · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

WHAT IS THIS PLAIN LANGUAGE SUMMARY ABOUT?: This plain language summary describes the results of a study looking at the effects of a medicine called ARRY-371797 (also known as PF-07265803) in people with dilated cardiomyopathy (DCM for short) caused by a faulty WHAT WERE THE RESULTS?: 12 American people (average age 50 years) with LMNA-related DCM took part in the study and received 400 mg or 100 mg of ARRY-371797 twice daily for 48 weeks. People knew which dose of ARRY-371797 they were taking. People were checked after 4, 12, 24, 36 and 48 weeks of taking ARRY-371797 to see how far they could walk in the 6-minute walk test (6MWT for short). The level of NT-proBNP in their blood was also measured. NT-proBNP is a biomarker used to measure the severity of heart failure. A biomarker is something found in the body that can be measured to indicate the extent of a disease. -After taking ARRY-371797 for 12 weeks, people were able to walk further in the 6MWT and had lower levels of NT-proBNP in their blood. This suggests improvement in functional capacity (exercise tolerance) and heart function. Researchers also asked people about their quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ for short), and looked for any side effects. -Researchers saw some improvement in KCCQ scores. -Researchers saw no major side effects that they considered to be related to ARRY-371797 treatment. A side effect is something that people feel was caused by a medicine or treatment. Overall, this study showed that people with LMNA-related DCM who took ARRY-371797 had improved functional capacity (exercise tolerance), improved heart function, and improved quality of life. Phase 2 study (NCT02057341) Phase 2 long-term extension study (NCT02351856) Phase 3 REALM-DCM study (NCT03439514).

Indexed as

Cardiomyopathy, DilatedHeart FailureBiomarkersEthylenediaminesHumansIndazolesLamin Type AMiddle AgedMutationQuality of LifeARRY-371797BiomarkersEthylenediaminesIndazolesLamin Type ALMNA protein, humanlamin A/Clay summaryLMNA-related dilated cardiomyopathyp38 MAPKplain language summary

Identifiers

PMID36718638
OpenAlexW4318611980

What OpenQuestion holds

Textmetadata
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.