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 |