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

• ClinicalTrials.gov Identifier: NCT02012179
• Recruitment Status: Active, not recruiting
• First Posted: December 16, 2013
• Last Update Posted: July 11, 2022
• Sponsor: University of Alberta
• Information provided by (Responsible Party): University of Alberta

Tracking Information

• First Submitted Date: December 10, 2013
• First Posted Date: December 16, 2013
• Last Update Posted Date: July 11, 2022
• Actual Study Start Date: March 24, 2014
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Heart Failure

Intervention

Other: Low sodium diet

Low sodium diet (65 mmol or 1500 mg/day)

Study Arms

• 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 *

• Ezekowitz JA, Colin-Ramirez E, Ross H, Escobedo J, Macdonald P, Troughton R, Saldarriaga C, Alemayehu W, McAlister FA, Arcand J, Atherton J, Doughty R, Gupta M, Howlett J, Jaffer S, Lavoie A, Lund M, Marwick T, McKelvie R, Moe G, Pandey AS, Porepa L, Rajda M, Rheault H, Singh J, Toma M, Virani S, Zieroth S; SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 2022 Apr 2. Erratum In: Lancet. 2022 Oct 8;400(10359):1194.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 7, 2022): 806
• Original Estimated Enrollment (submitted: December 10, 2013): 1000
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, Chile, Mexico, New Zealand

Administrative Information

• NCT Number: NCT02012179
• Other Study ID Numbers: MOP130275
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Alberta
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alberta
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Justin Ezekowitz, MBBCh; University of Alberta

• PRS Account: University of Alberta
• Verification Date: July 2021