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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02012179
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : January 31, 2023
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Low sodium diet Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 806 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
Actual Study Start Date : March 24, 2014
Actual Primary Completion Date : September 2022
Actual Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Composite Clinical Outcomes [ Time Frame: 12 months ]
    All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits

Secondary Outcome Measures :
  1. Exercise capacity [ Time Frame: 12 months ]
    Change in exercise capacity as measured by the 6-minute walk test (6MWT)

  2. NYHA functional class [ Time Frame: 12 months ]
    Change in NYHA class treated as a categorical variable

  3. Quality of life (KCCQ) [ Time Frame: 12 months ]
    Change in quality of life assessed by the KCCQ

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02012179

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Sponsors and Collaborators
University of Alberta
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Principal Investigator: Justin Ezekowitz, MBBCh University of Alberta
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Alberta Identifier: NCT02012179    
Other Study ID Numbers: MOP130275
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Alberta:
Dietary sodium reduction
Salt restriction
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases