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

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ClinicalTrials.gov Identifier: NCT02012179
Recruitment Status : Recruiting
First Posted : December 16, 2013
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE December 10, 2013
First Posted Date  ICMJE December 16, 2013
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
Composite Clinical Outcomes [ Time Frame: 12 months ]
All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02012179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • 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 (KCCQ) [ Time Frame: 12 months ]
    Change in quality of life assessed by the KCCQ
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure
Official Title  ICMJE The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Other: Low sodium diet
Low sodium diet (65 mmol or 1500 mg/day)
Study Arms  ICMJE
  • Experimental: Low sodium diet
    Low sodium diet (65 mmol or 1500 mg/day)
    Intervention: Other: Low sodium diet
  • No Intervention: Usual Care
    General advice to limit dietary sodium as it is provided during routine clinic practice
Publications * Colin-Ramirez E, Ezekowitz JA; SODIUM-HF investigators. Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF). Am Heart J. 2018 Nov;205:87-96. doi: 10.1016/j.ahj.2018.08.005. Epub 2018 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2013)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eloisa Colin, PhD sodiumhf@ualberta.ca
Contact: Justin Ezekowitz, MBBCh sodiumhf@ualberta.ca
Listed Location Countries  ICMJE Australia,   Canada,   Chile,   Mexico,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02012179
Other Study ID Numbers  ICMJE MOP130275
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Justin Ezekowitz, MBBCh University of Alberta
PRS Account University of Alberta
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP