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: NCT01480401
Recruitment Status : Completed
First Posted : November 28, 2011
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.

Condition or disease Intervention/treatment Phase
Heart Failure Other: low-sodium diet (1500 mg daily) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 :
  1. symptoms and quality of life [ Time Frame: 12 months ]
    improves symptoms and quality of life for patients with stable HF

  2. reduces natriuretic peptide levels [ Time Frame: 12 months ]
    reduces natriuretic peptide levels

Information from the National Library of Medicine

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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 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.

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): 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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Alberta Identifier: NCT01480401     History of Changes
Other Study ID Numbers: 82-SH-01
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases