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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Alberta
Information provided by (Responsible Party):
University of Alberta Identifier:
First received: December 10, 2013
Last updated: March 31, 2017
Last verified: September 2016
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 Intervention Phase
Heart Failure
Other: Low sodium diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ]
    All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits

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

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

  • Quality of life [ Time Frame: 12 months ]
    Change in quality of life assessed by the KCCQ

Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  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: NCT02012179

Contact: Eloisa Colin, PhD
Contact: Justin Ezekowitz, MBBCh

St. Vincent's Hospital Recruiting
Darlinghurst, Australia
Principal Investigator: Peter MacDonald         
Canada, Alberta
University of Calgary / Foothills Medical Centre Recruiting
Calgary, Alberta, Canada
Principal Investigator: Jonathan Howlett, MD         
St. Mary's Hospital Recruiting
Camrose, Alberta, Canada
Sub-Investigator: Mikael Hanninen, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Eloisa Colin, PhD   
Principal Investigator: Justin Ezekowitz, MBBCh         
Red Deer Regional Hospital Recruiting
Red Deer, Alberta, Canada
Principal Investigator: Jitendra Singh, MD         
Canada, British Columbia
Private Cardiology Practice Recruiting
Delta, British Columbia, Canada
Principal Investigator: Shahin Jaffer, MD         
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Mustafa Toma, MD         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Sean Virani, MS         
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada
Principal Investigator: Shelley Zieroth, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada
Principal Investigator: Miroslaw Rajda, MD         
Canada, Ontario
Brampton Research Associates Recruiting
Brampton, Ontario, Canada
Principal Investigator: Milan Gupta, MD         
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
Principal Investigator: Eva Lonn, MD         
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada
Principal Investigator: Liane Porepa         
Curans Heart Centre Recruiting
Thunder Bay, Ontario, Canada
Principal Investigator: Christopher Lai, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Principal Investigator: Gordon Moe, MD         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada
Principal Investigator: Heather Ross, MD         
Hospital Base Osorno Recruiting
Osorno, Chile
Principal Investigator: Paz Bourke         
Centro de estudios cardiologicas y de Medicine Interna Ltda (Centre for Cardiology and Internal Medicine Studies) Recruiting
Temuco, Chile
Principal Investigator: Fernando Lanas, MD         
Unidad de Investigación en Epidemiología Clínica Hospital General Regional No. 1, IMSS Recruiting
Mexico City, Mexico
Principal Investigator: Jorge Escobedo, MD         
New Zealand
Christchurch Heart Institute / University of Otago Recruiting
Christchurch, New Zealand
Principal Investigator: Richard Troughton         
Sponsors and Collaborators
University of Alberta
Principal Investigator: Justin Ezekowitz, MBBCh University of Alberta
  More Information

Responsible Party: University of Alberta Identifier: NCT02012179     History of Changes
Other Study ID Numbers: MOP130275
Study First Received: December 10, 2013
Last Updated: March 31, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Alberta:
Dietary sodium reduction
Salt restriction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017