Heart Failure
Conditions
Keywords
Diet, Dietary sodium reduction, Salt restriction, Nutrition
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.
Interventions
OTHERLow sodium diet
Low sodium diet (65 mmol or 1500 mg/day)
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Clinical Outcomes | 12 months | All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | 12 months | Change in exercise capacity as measured by the 6-minute walk test (6MWT) |
| NYHA functional class | 12 months | Change in NYHA class treated as a categorical variable |
| Quality of life (KCCQ) | 12 months | Change in quality of life assessed by the KCCQ |
Countries
Australia, Canada, Chile, Mexico, New Zealand
Outcome results
None listed