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

This study is currently recruiting participants.
Verified November 2017 by University of Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT02012179
First Posted: December 16, 2013
Last Update Posted: November 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Alberta
  Purpose
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: Single (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

  Eligibility

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.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT02012179


Contacts
Contact: Eloisa Colin, PhD sodiumhf@ualberta.ca
Contact: Justin Ezekowitz, MBBCh sodiumhf@ualberta.ca

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

Additional Information:
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02012179     History of Changes
Other Study ID Numbers: MOP130275
First Submitted: December 10, 2013
First Posted: December 16, 2013
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases