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

This study has been completed.
Information provided by (Responsible Party):
University of Alberta Identifier:
First received: November 23, 2011
Last updated: December 17, 2014
Last verified: December 2014
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.

Condition Intervention
Heart Failure
Other: low-sodium diet (1500 mg daily)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • composite clinical outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    (cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF

Secondary Outcome Measures:
  • symptoms and quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    improves symptoms and quality of life for patients with stable HF

  • reduces natriuretic peptide levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    reduces natriuretic peptide levels

Enrollment: 38
Study Start Date: March 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low-sodium diet
(1500 mg daily)
Other: low-sodium diet (1500 mg daily)
No Intervention: moderate-sodium diet
sodium (100 mmol or 2300 mg daily; Usual Care)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent.

Exclusion Criteria:

  • Subjects will be excluded if they have severe hyponatremia (serum sodium <130 mmol/L)
  • Renal failure (a glomerular filtration rate < 30 mL/min)
  • Uncontrolled thyroid disorders
  • Hepatic failure
  • Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months
  • Uncontrolled atrial fibrillation or recurrent ventricular arrhythmias
  • Malignancy, or with moderate-severe dementia.
  • Patients will be excluded if, in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.
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Please refer to this study by its identifier: NCT01480401

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Principal Investigator: Justin Ezekowitz, MBBCh MSc University of Alberta
  More Information

Additional Information:
Responsible Party: University of Alberta Identifier: NCT01480401     History of Changes
Other Study ID Numbers: 82-SH-01 
Study First Received: November 23, 2011
Last Updated: December 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Patients with stable heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on April 27, 2016