PMID- 34966917
OWN - NLM
STAT- MEDLINE
DCOM- 20220408
LR  - 20220505
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Linking)
VI  - 43
IP  - 14
DP  - 2022 Apr 6
TI  - Kidney function assessment and endpoint ascertainment in clinical trials.
PG  - 1379-1400
LID - 10.1093/eurheartj/ehab832 [doi]
AB  - 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.
CI  - Published on behalf of the European Society of Cardiology. All rights reserved. (c) 
      The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.
FAU - Khan, Muhammad Shahzeb
AU  - Khan MS
AD  - Division of Cardiology, Duke University School of Medicine, 2301 Erwin Road, 
      Durham, NC 27708, USA.
FAU - Bakris, George L
AU  - Bakris GL
AUID- ORCID: 0000-0003-1183-1267
AD  - Department of Medicine, University of Chicago Medicine, 5801 S Ellis Ave, 
      Chicago, IL 60637, USA.
FAU - Packer, Milton
AU  - Packer M
AUID- ORCID: 0000-0003-1828-2387
AD  - Division of Cardiology, Baylor University Medical Center, 3500 Gaston Ave, 
      Dallas, TX 75246, USA.
FAU - Shahid, Izza
AU  - Shahid I
AD  - Department of Medicine, Ziauddin University, Shahrah-e-Ghalib Clifton, Karachi, 
      Sindh 75000, Pakistan.
FAU - Anker, Stefan D
AU  - Anker SD
AUID- ORCID: 0000-0003-3331-7314
AD  - Department of Cardiology (CVK), Charite-Universitatsmedizin Berlin, Charitepl. 1, 
      Berlin 10117, Germany.
AD  - Berlin Institute of Health Center for Regenerative Therapies (BCRT), Fohrer Str. 
      15, Berlin 13353, Germany.
AD  - German Centre for Cardiovascular Research (DZHK), Partner Site, Potsdamer Str. 
      58, Berlin 10785, Germany.
FAU - Fonarow, Gregg C
AU  - Fonarow GC
AUID- ORCID: 0000-0002-3192-8093
AD  - Cardiology Division, University of California, Los Angeles, CA 90095, USA.
FAU - Wanner, Christoph
AU  - Wanner C
AUID- ORCID: 0000-0001-9507-5301
AD  - Division of Nephrology, Department of Medicine, University Hospital Wurzburg, 
      Josef-Schneider-Strasse 2, Wurzburg 97080, Germany.
FAU - Weir, Matthew R
AU  - Weir MR
AD  - Division of Nephrology, University of Maryland School of Medicine, 655 W 
      Baltimore St S, Baltimore, MD 21201, USA.
FAU - Zannad, Faiez
AU  - Zannad F
AUID- ORCID: 0000-0001-7456-1570
AD  - Institut Lorrain du Coeur et des Vaisseaux, 5 Rue du Morvan, 54500 
      Vandoeuvre-les-Nancy, France.
FAU - Butler, Javed
AU  - Butler J
AUID- ORCID: 0000-0003-4267-6933
AD  - Department of Medicine, University of Mississippi, 2500 N State Street, Jackson, 
      MS 39216, USA.
LA  - eng
PT  - Journal Article
PT  - Systematic Review
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
SB  - IM
MH  - Albuminuria/complications
MH  - *Diabetes Mellitus, Type 2/complications
MH  - Glomerular Filtration Rate
MH  - *Heart Failure
MH  - Humans
MH  - Kidney
MH  - *Renal Insufficiency, Chronic/complications
OTO - NOTNLM
OT  - Cardiovascular trials
OT  - Heart failure
OT  - Kidney function
OT  - eGFR slope
EDAT- 2021/12/31 06:00
MHDA- 2022/04/09 06:00
CRDT- 2021/12/30 05:45
PHST- 2021/02/12 00:00 [received]
PHST- 2021/05/24 00:00 [revised]
PHST- 2021/12/07 00:00 [accepted]
PHST- 2021/12/31 06:00 [pubmed]
PHST- 2022/04/09 06:00 [medline]
PHST- 2021/12/30 05:45 [entrez]
AID - 6489604 [pii]
AID - 10.1093/eurheartj/ehab832 [doi]
PST - ppublish
SO  - Eur Heart J. 2022 Apr 6;43(14):1379-1400. doi: 10.1093/eurheartj/ehab832.