This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Intervention Model: Parallel Assignment
Masking: Double (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 ]
    (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 ]
    improves symptoms and quality of life for patients with stable HF

  • reduces natriuretic peptide levels [ Time Frame: 12 months ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on September 21, 2017