Valsartan in early-stage hypertrophic cardiomyopathy: a randomized phase 2 trial. (Record no. 990)

MARC details
000 -LEADER
fixed length control field 03446nam a22004817a 4500
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20230312211513.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 211101s20212021 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1078-8956
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
Transcribing agency whc
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 34556856
245 ## - TITLE STATEMENT
Title Valsartan in early-stage hypertrophic cardiomyopathy: a randomized phase 2 trial.
251 ## - Source
Source Nature Medicine. 27(10):1818-1824, 2021 10.
252 ## - Abbreviated Source
Abbreviated source Nat Med. 27(10):1818-1824, 2021 10.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2021
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2022
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2021-11-01
520 ## - SUMMARY, ETC.
Abstract Hypertrophic cardiomyopathy (HCM) is often caused by pathogenic variants in sarcomeric genes and characterized by left ventricular (LV) hypertrophy, myocardial fibrosis and increased risk of heart failure and arrhythmias. There are no existing therapies to modify disease progression. In this study, we conducted a multi-center, double-blind, placebo-controlled phase 2 clinical trial to assess the safety and efficacy of the angiotensin II receptor blocker valsartan in attenuating disease evolution in early HCM. In total, 178 participants with early-stage sarcomeric HCM were randomized (1:1) to receive valsartan (320 mg daily in adults; 80-160 mg daily in children) or placebo for 2 years ( NCT01912534 ). Standardized changes from baseline to year 2 in LV wall thickness, mass and volumes; left atrial volume; tissue Doppler diastolic and systolic velocities; and serum levels of high-sensitivity troponin T and N-terminal pro-B-type natriuretic protein were integrated into a single composite z-score as the primary outcome. Valsartan (n = 88) improved cardiac structure and function compared to placebo (n = 90), as reflected by an increase in the composite z-score (between-group difference +0.231, 95% confidence interval (+0.098, +0.364); P = 0.001), which met the primary endpoint of the study. Treatment was well-tolerated. These results indicate a key opportunity to attenuate disease progression in early-stage sarcomeric HCM with an accessible and safe medication. Copyright (c) 2021. The Author(s), under exclusive licence to Springer Nature America, Inc.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Cardiomyopathy, Hypertrophic/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Heart Failure/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Heart/de [Drug Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Valsartan/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adolescent
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adult
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Cardiomyopathy, Hypertrophic/pp [Physiopathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Double-Blind Method
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Heart Failure/pp [Physiopathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Heart/pp [Physiopathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Male
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Middle Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Valsartan/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Young Adult
656 ## - INDEX TERM--OCCUPATION
Department MedStar Heart and Vascular Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Vargas, Jose D
9 (RLIN) 56
790 ## - Authors
All authors Axelsson A, Bach RG, Becker JR, Benson L, Braunwald , Bundgaard H, Burns KM, Canter C, Cirino AL, Colan SD, Day SM, Ho CY, Lakdawala NK, Lever HM, MacRae CA, Margossian R, McMurray JJV, Mestroni L, Murphy AM, Orav EJ, Owens AT, Patel AR, Pereira AC, Rossano JW, Russell MW, Seidman CE, Solomon SD, Soslow JH, Taylor MRG, Thrush P, VANISH Investigators, Vargas JD, Wheeler MT, Wilmot I, Zahka K
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1038/s41591-021-01505-4">https://dx.doi.org/10.1038/s41591-021-01505-4</a>
Public note https://dx.doi.org/10.1038/s41591-021-01505-4
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Source of classification or shelving scheme Dewey Decimal Classification
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
    Dewey Decimal Classification     MedStar Authors Catalog MedStar Authors Catalog 11/01/2021   34556856 34556856 11/01/2021 11/01/2021 Journal Article

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