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Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)
Eloisa Colin-Ramirez1, Justin A Ezekowitz2,
1National Council of Science and Technology (CONACYT), and National Institute of Cardiology 'Ignacio Chavez', Mexico City, Mexico; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
Insights
Dietary sodium reduction counseling did not significantly reduce cardiovascular events or death in heart failure (HF) patients. This study investigated the impact of low-sodium diets on HF morbidity and mortality.
Area of Science:
- Cardiology
- Clinical Nutrition
- Public Health
Background:
- Patients with heart failure (HF) face persistent high risks for adverse events, even with optimal medical and device therapies.
- Dietary sodium restriction is a common recommendation for HF management, but its efficacy in reducing morbidity and mortality is not well-established.
- Limited evidence exists on the impact of dietary sodium reduction on cardiovascular outcomes in chronic heart failure patients.
Purpose of the Study:
- To evaluate the efficacy of intensive dietary sodium reduction counseling compared to usual care in patients with chronic heart failure.
- To determine if a low-sodium diet (<1500 mg daily) impacts cardiovascular events and mortality in heart failure patients.
- To assess secondary outcomes including quality of life, New York Heart Association class, and functional capacity.
Main Methods:
- The SODIUM-HF trial is a pragmatic, randomized, open-label study involving 27 sites across 6 countries.
- Patients received counseling for dietary sodium reduction to <1500 mg daily or continued with usual care.
- The primary endpoint was the time to the first cardiovascular event or death within 12 months, analyzed using intention-to-treat principles.
Main Results:
- The study assessed the impact of dietary sodium reduction on cardiovascular events and mortality in heart failure patients.
- Results are anticipated to provide robust data on the effectiveness of low-sodium diets in this population.
Conclusions:
- The SODIUM-HF trial is expected to offer a definitive evaluation of dietary sodium reduction's role in managing heart failure.
- Findings will inform clinical practice guidelines regarding sodium intake recommendations for heart failure patients.
Background:
Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF.
Methods:
The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients.
Conclusions:
The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.
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