Filippo Crea
doi : 10.1093/eurheartj/ehac158
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1365–1368
Ana Mocumbi, Edna Lichucha, Karen Sliwa
doi : 10.1093/eurheartj/ehab671
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1369–1371
Mark Nicholls
doi : 10.1093/eurheartj/ehab591
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1372–1374
Judith Ozkan
doi : 10.1093/eurheartj/ehab574
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1375–1376
Massimo Volpe, Carlo Patrono
doi : 10.1093/eurheartj/ehac062
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1377–1378
Muhammad Shahzeb Khan, George L Bakris, Milton Packer, Izza Shahid, Stefan D Anker, Gregg C Fonarow, Christoph Wanner, Matthew R Weir, Faiez Zannad, Javed Butler
doi : 10.1093/eurheartj/ehab832
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1379–1400
Heterogeneity in the reporting of kidney function, kidney outcomes, and definitions for kidney endpoints in clinical trials makes it challenging to compare results and gauge incremental benefit of interventions across trials. We conducted a systematic review of the ascertainment of baseline kidney variables, reporting of kidney endpoints, and definitions used to characterize these endpoints in type 2 diabetes mellitus (T2DM), kidney, and heart failure (HF) trials. Medline, Scopus, and ClinicalTrials.gov were searched from January 2014 through January 2021 for large (>1000 participants) T2DM, HF, and kidney disease trials and their secondary analyses. Trial publication and supplementary appendices were searched to abstract relevant data. Thirty-three trials (16 T2DM; 10 HF; 7 kidney diseases) were included. Thirteen trials did not include patients with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 and for trials that did, representation of this cohort ranged from 0.1% to 15%. Reporting of baseline kidney function and albuminuria remained low, especially in HF trials. Variability was observed in the definition of chronic kidney disease, sustained decline in eGFR, end-stage kidney disease, kidney death, and kidney composite endpoint across trials. eGFR slope was reported in less than half trials, with differences observed in statistical models, definition of acute or chronic slope, and follow-up duration across trials. Significant heterogeneity in reporting of kidney function and kidney outcomes in large T2DM, kidney, and HF trials underscores the need for future stakeholders to draft a consensus solution. Detailed profiling of patients at baseline, accrual of more patients with advanced kidney disease, and standardization of definitions in trials may improve the ability to compare the results across trials.
Jean-Claude Tardif, Ewa Karwatowska-Prokopczuk, Eric St Amour, Christie M Ballantyne, Michael D Shapiro, Patrick M Moriarty, Seth J Baum, Eunju Hurh, Victoria J Bartlett, Joyce Kingsbury, Amparo L Figueroa, Veronica J Alexander, Joseph Tami, Joseph L Witztum, Richard S Geary, Louis St L O’Dea, Sotirios Tsimikas, Daniel Gaudet
doi : 10.1093/eurheartj/ehab820
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1401–1412
Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated antisense oligonucleotide targeted to hepatic APOC3 mRNA to inhibit apolipoprotein C-III (apoC-III) production, in lowering triglyceride levels in patients at high risk for or with established cardiovascular disease.
Robert A. Hegele
doi : 10.1093/eurheartj/ehab890
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1413–1415
The HPS3/TIMI55-REVEAL Collaborative Group, Writing Committee, E Sammons, J C Hopewell, F Chen, W Stevens, K Wallendszus, E Valdes-Marquez, R Dayanandan, C Knott, K Murphy, E Wincott, A Baxter, R Goodenough, M Lay, M Hill, S Macdonnell, G Fabbri, D Lucci, M Fajardo-Moser, S Brenner, D Hao, H Zhang, J Liu, B Wuhan, S Mosegaard, W Herrington, C Wanner, C Angermann, G Ertl, A Maggioni, P Barter, B Mihaylova, Y Mitchel, R Blaustein, S Goto, J Tobert, P DeLucca, Y Chen, Z Chen, A Gray, R Haynes, J Armitage, C Baigent, S Wiviott, C Cannon, E Braunwald, R Collins, L Bowman, M Landray, REVEAL Collaborative Group
doi : 10.1093/eurheartj/ehab863
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1416–1424
REVEAL was the first randomized controlled trial to demonstrate that adding cholesteryl ester transfer protein inhibitor therapy to intensive statin therapy reduced the risk of major coronary events. We now report results from extended follow-up beyond the scheduled study treatment period.
Ulrich Laufs, Thimoteus Speer
doi : 10.1093/eurheartj/ehab889
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1425–1427
Bertram Pitt, João Pedro Ferreira, Faiez Zannad
doi : 10.1093/eurheartj/ehab717
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1428–1431
Faiez Zannad, Cynthia Chauhan, Patrick O Gee, Sr, Nick Hartshorne-Evans, Adrian F Hernandez, Marilyn K Mann, Robin Martinez, Roxana Mehran
doi : 10.1093/eurheartj/ehab835
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1432–1437
Patients are ultimately the end-users of medical therapies and need to be actively integrated as contributors and decision-makers in the process of product development throughout product lifecycles. This is increasingly being recognized by patients, investigators, regulators, payers, sponsors, and medical journals. However, cardiovascular research remains behind other fields in terms of the extent of patient involvement and awareness of clinical trials in cardiovascular research. True patient partnerships in cardiovascular therapeutic development may permit more rapid recognition of unmet needs, ensure alignment of product development priorities with patient priorities, improve efficiency of trials (e.g. recruitment), and ensure outcomes of value to patients are being measured in trials (e.g. quality of life). This paper reviews ongoing initiatives and remaining opportunities to accomplish contributive patient involvement in cardiovascular clinical research.
Jian Zhu, Bin Huang, Er-Ping Xi, Xu-Hui Gao
doi : 10.1093/eurheartj/ehab288
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1438–1439
Benedict McDonaugh, Natalia Perepelova, Peter Kellman, James B Galloway, Stefania Rosmini
doi : 10.1093/eurheartj/ehab341
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Pages 1440–1441
Alessandro Malagoli, Simona Chiusolo, Stefano Tondi
doi : 10.1093/eurheartj/ehab404
European Heart Journal, Volume 43, Issue 14, 7 April 2022, Page 1442
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