SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure
NCT02012179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 806
Last updated 2023-01-31
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.
Conditions
Interventions
- OTHER
-
Low sodium diet
Low sodium diet (65 mmol or 1500 mg/day)
Sponsors & Collaborators
-
University of Alberta
lead OTHER
Principal Investigators
-
Justin Ezekowitz, MBBCh · University of Alberta
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-24
- Primary Completion
- 2022-09-30
- Completion
- 2023-01-31
Countries
- Australia
- Canada
- Chile
- Mexico
- New Zealand
Study Locations
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