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

• ClinicalTrials.gov Identifier: NCT02012179
• Recruitment Status: Recruiting
• First Posted: December 16, 2013
• Last Update Posted: April 8, 2019
• 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: April 8, 2019
• Study Start Date: January 2014
• Estimated Primary Completion Date: December 2020 (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
• Change History: Complete list of historical versions of study NCT02012179 on ClinicalTrials.gov Archive Site

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 *: 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: Recruiting
• Estimated Enrollment (submitted: December 10, 2013): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2020 (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: Eloisa Colin, PhD; sodiumhf@ualberta.ca

Contact: Justin Ezekowitz, MBBCh; sodiumhf@ualberta.ca

• 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

• Responsible Party: University of Alberta
• Study Sponsor: University of Alberta
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Alberta
• Verification Date: April 2019