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

Study Overview
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Brief Summary
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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.

Official Title
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The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Low sodium diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low sodium diet<br>Low sodium diet (65 mmol or 1500 mg/day) | Other: Low sodium diet<br>* Low sodium diet (65 mmol or 1500 mg/day)<br>|
| No Intervention: Usual Care<br>General advice to limit dietary sodium as it is provided during routine clinic practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Clinical Outcomes | All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | Change in exercise capacity as measured by the 6-minute walk test (6MWT) | 12 months | 
| NYHA functional class | Change in NYHA class treated as a categorical variable | 12 months | 
| Quality of life (KCCQ) | Change in quality of life assessed by the KCCQ | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Dietary sodium reduction, Salt restriction, Nutrition