PMID- 35381194
OWN - NLM
STAT- MEDLINE
DCOM- 20220412
LR  - 20221010
IS  - 1474-547X (Electronic)
IS  - 0140-6736 (Linking)
VI  - 399
IP  - 10333
DP  - 2022 Apr 9
TI  - Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): 
      an international, open-label, randomised, controlled trial.
PG  - 1391-1400
LID - S0140-6736(22)00369-5 [pii]
LID - 10.1016/S0140-6736(22)00369-5 [doi]
AB  - BACKGROUND: Dietary restriction of sodium has been suggested to prevent fluid 
      overload and adverse outcomes for patients with heart failure. We designed the 
      Study of Dietary Intervention under 100 mmol in Heart Failure (SODIUM-HF) to test 
      whether or not a reduction in dietary sodium reduces the incidence of future 
      clinical events. METHODS: SODIUM-HF is an international, open-label, randomised, 
      controlled trial that enrolled patients at 26 sites in six countries (Australia, 
      Canada, Chile, Colombia, Mexico, and New Zealand). Eligible patients were aged 18 
      years or older, with chronic heart failure (New York Heart Association [NYHA] 
      functional class 2-3), and receiving optimally tolerated guideline-directed 
      medical treatment. Patients were randomly assigned (1:1), using a standard number 
      generator and varying block sizes of two, four, or six, stratified by site, to 
      either usual care according to local guidelines or a low sodium diet of less than 
      100 mmol (ie, <1500 mg/day). The primary outcome was the composite of 
      cardiovascular-related admission to hospital, cardiovascular-related emergency 
      department visit, or all-cause death within 12 months in the intention-to-treat 
      (ITT) population (ie, all randomly assigned patients). Safety was assessed in the 
      ITT population. This study is registered with ClinicalTrials.gov, NCT02012179, 
      and is closed to accrual. FINDINGS: Between March 24, 2014, and Dec 9, 2020, 806 
      patients were randomly assigned to a low sodium diet (n=397) or usual care 
      (n=409). Median age was 67 years (IQR 58-74) and 268 (33%) were women and 538 
      (66%) were men. Between baseline and 12 months, the median sodium intake 
      decreased from 2286 mg/day (IQR 1653-3005) to 1658 mg/day (1301-2189) in the low 
      sodium group and from 2119 mg/day (1673-2804) to 2073 mg/day (1541-2900) in the 
      usual care group. By 12 months, events comprising the primary outcome had 
      occurred in 60 (15%) of 397 patients in the low sodium diet group and 70 (17%) of 
      409 in the usual care group (hazard ratio [HR] 0.89 [95% CI 0.63-1.26]; p=0.53). 
      All-cause death occurred in 22 (6%) patients in the low sodium diet group and 17 
      (4%) in the usual care group (HR 1.38 [0.73-2.60]; p=0.32), 
      cardiovascular-related hospitalisation occurred in 40 (10%) patients in the low 
      sodium diet group and 51 (12%) patients in the usual care group (HR 0.82 
      [0.54-1.24]; p=0.36), and cardiovascular-related emergency department visits 
      occurred in 17 (4%) patients in the low sodium diet group and 15 (4%) patients in 
      the usual care group (HR 1.21 [0.60-2.41]; p=0.60). No safety events related to 
      the study treatment were reported in either group. INTERPRETATION: In ambulatory 
      patients with heart failure, a dietary intervention to reduce sodium intake did 
      not reduce clinical events. FUNDING: Canadian Institutes of Health Research and 
      the University Hospital Foundation, Edmonton, Alberta, Canada, and Health 
      Research Council of New Zealand.
CI  - Copyright (c) 2022 Elsevier Ltd. All rights reserved.
FAU - Ezekowitz, Justin A
AU  - Ezekowitz JA
AD  - Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada. Electronic 
      address: Jae2@ualberta.ca.
FAU - Colin-Ramirez, Eloisa
AU  - Colin-Ramirez E
AD  - Anahuac University, Mexico City, Mexico.
FAU - Ross, Heather
AU  - Ross H
AD  - Toronto General Hospital, Toronto, ON, Canada.
FAU - Escobedo, Jorge
AU  - Escobedo J
AD  - Instituto Mexicano del Seguro Social, Mexico City, Mexico.
FAU - Macdonald, Peter
AU  - Macdonald P
AD  - St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia.
FAU - Troughton, Richard
AU  - Troughton R
AD  - University of Otago, Dunedin, New Zealand.
FAU - Saldarriaga, Clara
AU  - Saldarriaga C
AD  - Centro Cardiovascular Colombiano Clinica Santa Maria (Clinica Cardio VID), 
      Antioquia, Columbia.
FAU - Alemayehu, Wendimagegn
AU  - Alemayehu W
AD  - Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.
FAU - McAlister, Finlay A
AU  - McAlister FA
AD  - Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.
FAU - Arcand, JoAnne
AU  - Arcand J
AD  - University of Ontario Institute of Technology, Oshawa, ON, Canada.
FAU - Atherton, John
AU  - Atherton J
AD  - The Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
FAU - Doughty, Robert
AU  - Doughty R
AD  - Auckland UniServices, Auckland, New Zealand.
FAU - Gupta, Milan
AU  - Gupta M
AD  - Brampton Research Associates, Brampton, ON, Canada.
FAU - Howlett, Jonathan
AU  - Howlett J
AD  - University of Calgary and Foothills Medical Centre, Calgary, AL, Canada.
FAU - Jaffer, Shahin
AU  - Jaffer S
AD  - University of British Columbia, Vancouver, BC, Canada.
FAU - Lavoie, Andrea
AU  - Lavoie A
AD  - Prairie Vascular Research Inc, Regina, SK, Canada.
FAU - Lund, Mayanna
AU  - Lund M
AD  - Middlemore Clinical Trials, Auckland, New Zealand.
FAU - Marwick, Thomas
AU  - Marwick T
AD  - Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.
FAU - McKelvie, Robert
AU  - McKelvie R
AD  - Hamilton Health Sciences, Hamilton, ON, Canada.
FAU - Moe, Gordon
AU  - Moe G
AD  - St Michael's Hospital, Toronto, ON, Canada.
FAU - Pandey, A Shekhar
AU  - Pandey AS
AD  - Cambridge Cardiac Care Centre, Cambridge, ON, Canada.
FAU - Porepa, Liane
AU  - Porepa L
AD  - Southlake Regional Health Centre, Newmarket, ON, Canada.
FAU - Rajda, Miroslaw
AU  - Rajda M
AD  - Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada.
FAU - Rheault, Haunnah
AU  - Rheault H
AD  - The Prince Charles Hospital, Chermside, QLD, Australia.
FAU - Singh, Jitendra
AU  - Singh J
AD  - Red Deer Regional Hospital, Red Deer, AL, Canada.
FAU - Toma, Mustafa
AU  - Toma M
AD  - St Paul's Hospital, Vancouver, BC, Canada.
FAU - Virani, Sean
AU  - Virani S
AD  - Vancouver General Hospital, Vancouver, BC, Canada.
FAU - Zieroth, Shelley
AU  - Zieroth S
AD  - St Boniface Hospital, Winnipeg, MB, Canada.
CN  - SODIUM-HF Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT02012179
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220402
PL  - England
TA  - Lancet
JT  - Lancet (London, England)
JID - 2985213R
RN  - 0 (Sodium, Dietary)
RN  - 9NEZ333N27 (Sodium)
SB  - IM
CIN - Lancet. 2022 Apr 9;399(10333):1361-1363. PMID: 35381195
CIN - Nat Rev Cardiol. 2022 Jun;19(6):352. PMID: 35422523
CIN - Ann Intern Med. 2022 Aug;175(8):JC88. PMID: 35914255
EIN - Lancet. 2022 Oct 8;400(10359):1194. PMID: 36216004
MH  - Aged
MH  - Canada
MH  - Female
MH  - *Heart Failure/drug therapy
MH  - Humans
MH  - Male
MH  - Sodium
MH  - *Sodium, Dietary
MH  - Treatment Outcome
COIS- Declaration of interests JAE reports research grants from American Regent, Amgen, 
      AstraZeneca, Bayer, Bristol-Myers Squibb/Pfizer, eko.ai, US2.ai, Merck, Novartis, 
      Otsuka, Sanofi, and Servier, and consulting fees from American Regent, Amgen, 
      AstraZeneca, Bayer, Bristol-Myers Squibb/Pfizer, Merck, Novartis, Otsuka, Sanofi, 
      and Servier. PM reports research grants from National Health & Medical Research 
      Committee, New South Wales Department of Health, and St Vincent's Clinic 
      Foundation; consulting fees from AstraZeneca, Boehringer Ingelheim, and Novartis; 
      honoraria payments from Japanese Circulation Society; support for attending 
      meetings or travel from Astellas; and stock or stock options from Infensa 
      Biologics. RT reports research grants from Health Research Council of New 
      Zealand; consulting fees from Merck and Roche Diagnostics; and honoraria payments 
      from Roche Diagnostics. CS reports research grants from Medtronic; consulting 
      fees from AstraZeneca, Bayer, Merck, and Boehringer Ingelheim; honoraria payments 
      from AstraZeneca, Bayer, Merck, Boehringer Ingelheim, and Novartis; and fees for 
      participation in advisory boards from Servier, AstraZeneca, Bayer, Merck, 
      Boehringer Ingelheim, and Novartis. JAt reports consulting fees from AstraZeneca, 
      Boehringer Ingelheim, and Eli Lilly and support for attending meetings from 
      AstraZeneca, Novartis, and Shire. MG reports research grants from the University 
      of Alberta. JH reports research grants from AstraZeneca; consulting fees from 
      Servier, Otsuka, Alnylam, Boehringer Ingelheim, Lilly, Novo Nordisk, Bayer 
      Canada, AstraZeneca, and Novartis; and honoraria payments from Servier, Otsuka, 
      Alnylam, Boehringer Ingelheim, Lilly, Novo Nordisk, Bayer Canada, AstraZeneca, 
      and Novartis. SJ reports research payments from the University of Alberta. ML 
      reports consulting fees from New Zealand Formulary and honoraria payment from 
      Novartis. JS reports consulting fees from Servier and Novartis; honoraria 
      payments from Bayer; and receipt of equipment, materials, drugs, medical writing, 
      gifts, or other services from Servier, Novartis, Bayer, and HLS Therapeutics. SZ 
      reports consulting fees from Abbott, Akcea, AstraZeneca, Amgen, Alnylam, Bayer, 
      Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Otsuka, Pfizer, Servier, and 
      Vifor; and honoraria payments from Amgen, AstraZeneca, Bayer, Boehringer 
      Ingelheim, Eli Lilly, HLS Therapeutics, Janssen, Novartis, Novo Nordisk, Servier, 
      and Vifor. All other authors declare no competing interests.
FIR - Ezekowitz, Justin
IR  - Ezekowitz J
FIR - Colin-Ramirez, Eloisa
IR  - Colin-Ramirez E
FIR - Ross, Heather
IR  - Ross H
FIR - Escobedo, Jorge
IR  - Escobedo J
FIR - Macdonald, Peter
IR  - Macdonald P
FIR - Troughton, Richard
IR  - Troughton R
FIR - Saldarriaga, Clara
IR  - Saldarriaga C
FIR - Alemayehu, Wendimagegn
IR  - Alemayehu W
FIR - McAlister, Finlay
IR  - McAlister F
FIR - Arcand, JoAnne
IR  - Arcand J
FIR - Atherton, John
IR  - Atherton J
FIR - Doughty, Robert
IR  - Doughty R
FIR - Gupta, Milan
IR  - Gupta M
FIR - Howlett, Jonathan
IR  - Howlett J
FIR - Jaffer, Shahin
IR  - Jaffer S
FIR - Lavoie, Andrea
IR  - Lavoie A
FIR - Lund, Mayanna
IR  - Lund M
FIR - Marwick, Thomas
IR  - Marwick T
FIR - McKelvie, Robert
IR  - McKelvie R
FIR - Moe, Gordon
IR  - Moe G
FIR - Pandey, A Shekhar
IR  - Pandey AS
FIR - Porepa, Liane
IR  - Porepa L
FIR - Rajda, Miroslaw
IR  - Rajda M
FIR - Rheault, Haunnah
IR  - Rheault H
FIR - Singh, Jitendra
IR  - Singh J
FIR - Toma, Mustafa
IR  - Toma M
FIR - Virani, Sean
IR  - Virani S
FIR - Zieroth, Shelley
IR  - Zieroth S
EDAT- 2022/04/06 06:00
MHDA- 2022/04/13 06:00
CRDT- 2022/04/05 20:09
PHST- 2022/02/06 00:00 [received]
PHST- 2022/02/16 00:00 [revised]
PHST- 2022/02/17 00:00 [accepted]
PHST- 2022/04/06 06:00 [pubmed]
PHST- 2022/04/13 06:00 [medline]
PHST- 2022/04/05 20:09 [entrez]
AID - S0140-6736(22)00369-5 [pii]
AID - 10.1016/S0140-6736(22)00369-5 [doi]
PST - ppublish
SO  - Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 
      2022 Apr 2.