Cardiac Remodeling in Subclinical Hypertrophic CardiomyopathyThe VANISH Randomized Clinical Trial

Página do item simplificado
dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorVISSING, Christoffer Rasmus
dc.contributor.authorRAJA, Anna Axelsson
dc.contributor.authorDAY, Sharlene M.
dc.contributor.authorRUSSELL, Mark W.
dc.contributor.authorZAHKA, Kenneth
dc.contributor.authorLEVER, Harry M.
dc.contributor.authorPEREIRA, Alexandre C.
dc.contributor.authorCOLAN, Steven D.
dc.contributor.authorMARGOSSIAN, Renee
dc.contributor.authorMURPHY, Anne M.
dc.contributor.authorCANTER, Charles
dc.contributor.authorBACH, Richard G.
dc.contributor.authorWHEELER, Matthew T.
dc.contributor.authorROSSANO, Joseph W.
dc.contributor.authorOWENS, Anjali T.
dc.contributor.authorBENSON, Lee
dc.contributor.authorMESTRONI, Luisa
dc.contributor.authorTAYLOR, Matthew R. G.
dc.contributor.authorPATEL, Amit R.
dc.contributor.authorWILMOT, Ivan
dc.contributor.authorTHRUSH, Philip
dc.contributor.authorSOSLOW, Jonathan H.
dc.contributor.authorBECKER, Jason R.
dc.contributor.authorSEIDMAN, Christine E.
dc.contributor.authorLAKDAWALA, Neal K.
dc.contributor.authorCIRINO, Allison L.
dc.contributor.authorMCMURRAY, John J. V.
dc.contributor.authorMACRAE, Calum A.
dc.contributor.authorSOLOMON, Scott D.
dc.contributor.authorBUNDGAARD, Henning
dc.contributor.authorORAV, E. John
dc.contributor.authorHO, Carolyn Y.
dc.contributor.groupauthorValsartan Attenuating Dis Evolutio
dc.date.accessioned2024-04-05T19:46:26Z
dc.date.available2024-04-05T19:46:26Z
dc.date.issued2023
dc.description.abstractImportance Valsartan has shown promise in attenuating cardiac remodeling in patients with early-stage sarcomeric hypertrophic cardiomyopathy (HCM). Genetic testing can identify individuals at risk of HCM in a subclinical stage who could benefit from therapies that prevent disease progression.Objective To explore the potential for valsartan to modify disease development, and to characterize short-term phenotypic progression in subclinical HCM.Design, Setting, and Participants The multicenter, double-blind, placebo-controlled Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy (VANISH) randomized clinical trial was conducted from April 2014 to July 2019 at 17 sites in 4 countries (Brazil, Canada, Denmark, and the US), with 2 years of follow-up. The prespecified exploratory VANISH cohort studied here included sarcomere variant carriers with subclinical HCM and early phenotypic manifestations (reduced E ' velocity, electrocardiographic abnormalities, or an increased left ventricular [LV] wall thickness [LVWT] to cavity diameter ratio) but no LV hypertrophy (LVH). Data were analyzed between March and December 2022.Interventions Treatment with placebo or valsartan (80 mg/d for children weighing <35 kg, 160 mg/d for children weighing >= 35 kg, or 320 mg/d for adults aged >= 18 years).Main Outcomes and Measures The primary outcome was a composite z score incorporating changes in 9 parameters of cardiac remodeling (LV cavity volume, LVWT, and LV mass; left atrial [LA] volume; E ' velocity and S ' velocity; and serum troponin and N-terminal prohormone of brain natriuretic peptide levels).Results This study included 34 participants, with a mean (SD) age of 16 (5) years (all were White). A total of 18 participants (8 female [44%] and 10 male [56%]) were randomized to valsartan and 16 (9 female [56%] and 7 male [44%]) were randomized to placebo. No statistically significant effects of valsartan on cardiac remodeling were detected (mean change in composite z score compared with placebo: -0.01 [95% CI, -0.29 to 0.26]; P = .92). Overall, 2-year phenotypic progression was modest, with only a mild increase in LA volume detected (increased by 3.5 mL/m(2) [95% CI, 1.4-6.0 mL/m(2)]; P = .002). Nine participants (26%) had increased LVWT, including 6 (18%) who developed clinically overt HCM. Baseline LA volume index (LAVI; 35 vs 28 mL/m(2); P = .01) and average interventricular septum thickness (8.5 vs 7.0 mm; P = .009) were higher in participants who developed HCM.Conclusions and Relevance In this exploratory cohort, valsartan was not proven to slow progression of subclinical HCM. Minimal changes in markers of cardiac remodeling were observed, although nearly one-fifth of patients developed clinically overt HCM. Transition to disease was associated with greater baseline interventricular septum thickness and LAVI. These findings highlight the importance of following sarcomere variant carriers longitudinally and the critical need to improve understanding of factors that drive disease penetrance and progression.eng
dc.description.indexMEDLINE
dc.description.indexPubMed
dc.description.indexScopus
dc.description.indexDimensions
dc.description.indexWoS
dc.description.sponsorshipNIH [1P50HL112349]
dc.identifier.citationJAMA CARDIOLOGY, v.8, n.11, 2023
dc.identifier.doi10.1001/jamacardio.2023.2808
dc.identifier.eissn2380-6591
dc.identifier.issn2380-6583
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/59295
dc.language.isoeng
dc.publisherAMER MEDICAL ASSOCeng
dc.relation.ispartofJama Cardiology
dc.rightsrestrictedAccesseng
dc.rights.holderCopyright AMER MEDICAL ASSOCeng
dc.subject.otherdiseaseeng
dc.subject.otherpenetranceeng
dc.subject.otherevolutioneng
dc.subject.otherdeatheng
dc.subject.otherriskeng
dc.subject.wosCardiac & Cardiovascular Systemseng
dc.titleCardiac Remodeling in Subclinical Hypertrophic CardiomyopathyThe VANISH Randomized Clinical Trialeng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countryDinamarca
hcfmusp.affiliation.countryEscócia
hcfmusp.affiliation.countryCanadá
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisodk
hcfmusp.affiliation.countryisoca
hcfmusp.affiliation.countryisogb
hcfmusp.author.externalVISSING, Christoffer Rasmus:Rigshosp, Copenhagen Univ Hosp, Dept Cardiol, Copenhagen, Denmark; Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
hcfmusp.author.externalRAJA, Anna Axelsson:Rigshosp, Copenhagen Univ Hosp, Dept Cardiol, Copenhagen, Denmark
hcfmusp.author.externalDAY, Sharlene M.:Univ Penn, Perelman Sch Med, Dept Med, Div Cardiovasc Med, Philadelphia, PA USA
hcfmusp.author.externalRUSSELL, Mark W.:Univ Michigan, Ann Arbor, MI USA
hcfmusp.author.externalZAHKA, Kenneth:Cleveland Clin Fdn, Cleveland, OH USA
hcfmusp.author.externalLEVER, Harry M.:Cleveland Clin Fdn, Cleveland, OH USA
hcfmusp.author.externalCOLAN, Steven D.:Boston Childrens Hosp, Dept Cardiol, Boston, MA USA
hcfmusp.author.externalMARGOSSIAN, Renee:Boston Childrens Hosp, Dept Cardiol, Boston, MA USA
hcfmusp.author.externalMURPHY, Anne M.:Johns Hopkins Univ, Div Pediat Cardiol, Sch Med, Dept Pediat, Baltimore, MD USA
hcfmusp.author.externalCANTER, Charles:Washington Univ, Sch Med, St. Louis, MO USA
hcfmusp.author.externalBACH, Richard G.:Washington Univ, Sch Med, St. Louis, MO USA
hcfmusp.author.externalWHEELER, Matthew T.:Stanford Univ, Dept Med, Sch Med, Div Cardiovasc Med, Stanford, CA USA
hcfmusp.author.externalROSSANO, Joseph W.:Childrens Hosp Philadelphia, Philadelphia, PA USA
hcfmusp.author.externalOWENS, Anjali T.:Univ Penn, Perelman Sch Med, Dept Med, Div Cardiovasc Med, Philadelphia, PA USA
hcfmusp.author.externalBENSON, Lee:Toronto Hosp Sick Children, Toronto, ON, Canada
hcfmusp.author.externalMESTRONI, Luisa:Univ Colorado Anschutz Med Campus, Dept Neurol & Neurosurg, Aurora, CO USA
hcfmusp.author.externalTAYLOR, Matthew R. G.:Univ Colorado Anschutz Med Campus, Dept Neurol & Neurosurg, Aurora, CO USA
hcfmusp.author.externalPATEL, Amit R.:Univ Virginia Hlth Syst, Dept Med, Cardiovasc Div, Charlottesville, VA USA
hcfmusp.author.externalWILMOT, Ivan:Cincinnati Childrens Hosp, Med Ctr, Heart Inst, Cincinnati, OH USA
hcfmusp.author.externalTHRUSH, Philip:Ann & Robert H Lurie Childrens Hosp Chicago, Chicago, IL USA
hcfmusp.author.externalSOSLOW, Jonathan H.:Vanderbilt Univ, Med Ctr, Nashville, TN USA
hcfmusp.author.externalBECKER, Jason R.:Univ Pittsburgh, Div Cardiol, Sch Med, Pittsburgh, PA USA; UPMC, Pittsburgh, PA USA
hcfmusp.author.externalSEIDMAN, Christine E.:Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA; Howard Hughes Med Inst, Chevy Chase, MD USA
hcfmusp.author.externalLAKDAWALA, Neal K.:Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
hcfmusp.author.externalCIRINO, Allison L.:Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
hcfmusp.author.externalMCMURRAY, John J. V.:Univ Glasgow, British Heart Fdn Cardiovasc Res Ctr, Glasgow City, Scotland
hcfmusp.author.externalMACRAE, Calum A.:Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
hcfmusp.author.externalSOLOMON, Scott D.:Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
hcfmusp.author.externalBUNDGAARD, Henning:Rigshosp, Copenhagen Univ Hosp, Dept Cardiol, Copenhagen, Denmark
hcfmusp.author.externalORAV, E. John:Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
hcfmusp.author.externalHO, Carolyn Y.:Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
hcfmusp.citation.scopus1
hcfmusp.contributor.author-fmusphcALEXANDRE DA COSTA PEREIRA
hcfmusp.description.issue11
hcfmusp.description.volume8
hcfmusp.origemWOS
hcfmusp.origem.dimensionspub.1163881687
hcfmusp.origem.pubmed37672268
hcfmusp.origem.scopus2-s2.0-85172304468
hcfmusp.origem.wosWOS:001085840800001
hcfmusp.publisher.cityCHICAGOeng
hcfmusp.publisher.countryUSAeng
hcfmusp.relation.referencede Marvao A, 2021, J AM COLL CARDIOL, V78, P1097, DOI 10.1016/j.jacc.2021.07.017eng
hcfmusp.relation.referenceGuttmann OP, 2017, HEART, V103, P672, DOI 10.1136/heartjnl-2016-309672eng
hcfmusp.relation.referenceHo CY, 2021, NAT MED, V27, P1818, DOI 10.1038/s41591-021-01505-4eng
hcfmusp.relation.referenceHo CY, 2018, CIRCULATION, V138, P1387, DOI 10.1161/CIRCULATIONAHA.117.033200eng
hcfmusp.relation.referenceHo CY, 2017, AM HEART J, V187, P145, DOI 10.1016/j.ahj.2017.02.008eng
hcfmusp.relation.referenceHo CY, 2016, HEART, V102, P1805, DOI 10.1136/heartjnl-2016-310015eng
hcfmusp.relation.referenceJensen MK, 2013, CIRCULATION, V127, P48, DOI 10.1161/CIRCULATIONAHA.111.090514eng
hcfmusp.relation.referenceLorenzini M, 2020, J AM COLL CARDIOL, V76, P550, DOI 10.1016/j.jacc.2020.06.011eng
hcfmusp.relation.referenceMichels M, 2009, EUR HEART J, V30, P2593, DOI 10.1093/eurheartj/ehp306eng
hcfmusp.relation.referenceRaja AA, 2019, CIRC-HEART FAIL, V12, DOI 10.1161/CIRCHEARTFAILURE.119.006231eng
hcfmusp.relation.referenceRaja AA, 2018, CIRCULATION, V138, P782, DOI 10.1161/CIRCULATIONAHA.117.032966eng
hcfmusp.relation.referenceRanthe MF, 2015, CIRCULATION, V132, P1013, DOI 10.1161/CIRCULATIONAHA.114.013478eng
hcfmusp.relation.referenceSachdev V, 2005, AM HEART J, V149, P730, DOI 10.1016/j.ahj.2004.07.017eng
hcfmusp.relation.referenceYang H, 2005, J AM SOC ECHOCARDIOG, V18, P1074, DOI 10.1016/j.echo.2005.06.011eng
hcfmusp.scopus.lastupdate2024-04-12
relation.isAuthorOfPublication415ce7ca-65c1-4699-b6f4-19dae8b03849
relation.isAuthorOfPublication.latestForDiscovery415ce7ca-65c1-4699-b6f4-19dae8b03849
Arquivos
Coleções
Artigos e Materiais de Revistas Científicas - HC/InCor