Evidence map›Paper›PMID 39217447›Full record

Trial reportEuropean heart journal2024

Cardiac biomarkers and effects of aficamten in obstructive hypertrophic cardiomyopathy: the SEQUOIA-HCM trial.

Caroline J Coats, Ahmad Masri, Roberto Barriales-Villa, Theodore P Abraham, Douglas Marshall Brinkley, Brian L Claggett, Albert Hagege, Sheila M Hegde, Carolyn Y Ho, Ian J Kulac and 14 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05186818 (A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT05186818 phase3completednot on this map

A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

TypeinterventionalSponsorCytokineticsRan2022 to 2023Enrolled282ConditionsObstructive Hypertrophic Cardiomyopathy (oHCM)ArmsAficamten (5 mg, 10 mg, 15 mg, and 20 mg), Placebo to match aficamten
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. 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

24 authors.

Caroline J CoatsSchool of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.ORCID 0000-0002-3208-470X
Ahmad MasriDivision of Cardiology, Department of Medicine, Oregon Health & Science University, Portland, OR, USA.ORCID 0000-0002-6390-6526
Roberto Barriales-VillaDepartment of Cardiology, Complexo Hospitalario Universitario A Coruña, INIBIC, CIBERCV-ISCIII, A Coruña, Spain.ORCID 0000-0002-6721-3487
Theodore P AbrahamUCSF Adult Cardiac Echocardiography Lab, University of California San Francisco, San Francisco, CA, USA.
Douglas Marshall BrinkleyDivision of Cardiovascular Medicine, Vanderbilt Heart & Vascular Institute, Nashville, TN, USA.
Brian L ClaggettCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-4215-9218
Albert HagegeDépartement de Cardiologie, Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Paris, France.ORCID 0000-0003-4685-6077
Sheila M HegdeCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Carolyn Y HoDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-7334-7924
Ian J KulacCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Matthew M Y LeeSchool of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
Martin S MaronDepartment of Cardiology, Lahey Hospital and Medical Center, Burlington, MA, USA.ORCID 0000-0002-9923-3853
Iacopo OlivottoDivision of Cardiology, Meyer Children's Hospital, Istituto di Ricovero e Cura a Carattere Scientifico, Florence, Italy.
Anjali T OwensCenter for Inherited Cardiovascular Disease, Division of Cardiovascular Medicine, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.ORCID 0000-0002-9669-8495
Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID 0000-0003-3698-9597
Jacob Tfelt-HansenSection of Forensic Genetics, Department of Forensic Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0003-3895-9316
Hugh WatkinsRadcliffe Department of Medicine, University of Oxford, Oxford, UK.ORCID 0000-0002-5287-9016
Daniel L JacobyClinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.ORCID 0000-0002-9182-275X
Stephen B HeitnerClinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.ORCID 0000-0003-2189-1474
Stuart KupferClinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.ORCID 0000-0002-5469-1287
Fady I MalikClinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.ORCID 0000-0002-5597-5759
Lisa MengClinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.
Amy WohltmanClinical Research, Cytokinetics, Incorporated, South San Francisco, CA, USA.
James L JanuzziDivision of Cardiology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA.ORCID 0000-0002-8338-1798

Funding

Adolph Hutter ProfessorshipCytokinetics, Incorporated
6 · The paper itself

Abstract

BACKGROUND AND

aimsThe role of biomarker testing in the management of obstructive hypertrophic cardiomyopathy is not well defined. This pre-specified analysis of SEQUOIA-HCM (NCT05186818) sought to define the associations between clinical characteristics and baseline concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (hs-cTnI), and to evaluate the effect of treatment with aficamten on biomarker concentrations.

methodsCardiac biomarkers were measured at baseline and serially throughout the study. Regression analyses determined predictors of baseline NT-proBNP and hs-cTnI concentrations, and evaluated whether early changes in these biomarkers relate to later changes in left ventricular outflow tract gradient (LVOT-G), other echocardiographic measures, health status, and functional capacity.

resultsBaseline concentration of NT-proBNP was associated with LVOT-G and measures of diastolic function, while hs-cTnI was associated with left ventricular thickness. Within 8 weeks of treatment with aficamten, NT-proBNP was reduced by 79% (95% confidence interval 76%-83%, P < .001) and hs-cTnI by 41% (95% confidence interval 32%-49%, P < .001); both biomarkers reverted to baseline after washout. Reductions in NT-proBNP and hs-cTnI by 24 weeks were strongly associated with a lowering of LVOT-G, improvement in health status, and increased peak oxygen uptake. N-Terminal pro-B-type natriuretic peptide reduction strongly correlated with the majority of improvements in exercise capacity. Furthermore, the change in NT-proBNP by Week 2 was associated with the 24-week change in key endpoints.

conclusionsN-Terminal pro-B-type natriuretic peptide and hs-cTnI concentrations are associated with key variables in obstructive hypertrophic cardiomyopathy. Serial measurement of NT-proBNP and hs-cTnI appears to reflect clinical response to aficamten therapy.

Indexed as

BiomarkersCardiomyopathy, HypertrophicNatriuretic Peptide, BrainPeptide FragmentsTroponin IAgedDouble-Blind MethodFemaleGrowth Differentiation Factor 15HumansMaleMiddle AgedBiomarkersGrowth Differentiation Factor 15Natriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)Troponin IAficamtenHypertrophic cardiomyopathyNatriuretic peptidesTroponin

Identifiers

PMID39217447
PMCPMC11544315

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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.