SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)

The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure

SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits. The hypothesis of this study is that patients following a low-sodium containing diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those randomized to Usual Care.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Low sodium diet

• Study Type: Interventional
• Enrollment (Actual): 806
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Chermside, Australia
    • The Prince Charles Hospital
  • Darlinghurst, Australia
    • St. Vincent's Hospital Sydney
  • Herston, Australia
    • Metro North Hospital and Health Service
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary / Foothills Medical Centre
    • Camrose, Alberta, Canada
      • St. Mary's Hospital
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital
    • Red Deer, Alberta, Canada
      • Red Deer Regional Hospital
  • British Columbia
    • Delta, British Columbia, Canada
      • Private Cardiology Practice
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada
      • St. Paul's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • St. Boniface Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Brampton, Ontario, Canada
      • Brampton Research Associates
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences
    • Newmarket, Ontario, Canada
      • Southlake Regional Health Centre
    • Thunder Bay, Ontario, Canada
      • Curans Heart Centre
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Toronto General Hospital
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Prairie Vascular Research Inc.
    • Saskatoon, Saskatchewan, Canada
      • Royal University Hospital
• Chile
  • Osorno, Chile
    • Hospital Base Osorno
  • Temuco, Chile
    • Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies)
• Mexico
  • Mexico City, Mexico
    • Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS
• New Zealand
  • Auckland, New Zealand
    • Middlemore Clinical Trials
  • Auckland, New Zealand
    • University of Auckland
  • Christchurch, New Zealand
    • Christchurch Heart Institute / University of Otago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent.

Exclusion Criteria:

Subjects will be excluded if:

• Average dietary intake of <1500 mg/ day by a quantitative or semi-quantitative method
• Serum sodium <130mmol/L
• Renal failure (glomerular filtration rate <30 mL/min)
• Hepatic failure
• Uncontrolled thyroid disorder
• Cardiac device (ICD or CRT) or revascularization procedure (PCI or CABG) in previous month or planned in next 3 months
• Hospitalization due to cardiovascular causes in previous 1 month
• Uncontrolled atrial fibrillation (resting heart rate >90 bpm)
• Active malignancy
• Moderate-severe dementia
• Enrolled in another interventional research study
• Patients will be excluded, if in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low sodium diet; Low sodium diet (65 mmol or 1500 mg/day)	Other: Low sodium diet; Low sodium diet (65 mmol or 1500 mg/day)
No Intervention: Usual Care; General advice to limit dietary sodium as it is provided during routine clinic practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Clinical Outcomes	All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Change in exercise capacity as measured by the 6-minute walk test (6MWT)	12 months
NYHA functional class	Change in NYHA class treated as a categorical variable	12 months
Quality of life (KCCQ)	Change in quality of life assessed by the KCCQ	12 months

Collaborators and Investigators

• Sponsor: University of Alberta

Publications and helpful links

General Publications

• Ezekowitz JA, Colin-Ramirez E, Ross H, Escobedo J, Macdonald P, Troughton R, Saldarriaga C, Alemayehu W, McAlister FA, Arcand J, Atherton J, Doughty R, Gupta M, Howlett J, Jaffer S, Lavoie A, Lund M, Marwick T, McKelvie R, Moe G, Pandey AS, Porepa L, Rajda M, Rheault H, Singh J, Toma M, Virani S, Zieroth S; SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 2022 Apr 2. Erratum in: Lancet. 2022 Oct 8;400(10359):1194.
• Colin-Ramirez E, Ezekowitz JA; SODIUM-HF investigators. Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF). Am Heart J. 2018 Nov;205:87-96. doi: 10.1016/j.ahj.2018.08.005. Epub 2018 Aug 16.

Helpful Links

• SODIUM-HF Webpage

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2014
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Nutrition; Diet; Dietary sodium reduction; Salt restriction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MOP130275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No