Using low-sodium salt to improve heart failure outcomes

Effects of Low-Sodium Substitute Salt on Death, Heart Failure Hospitalization, Heart Failure Emergency Department Visits, and Quality of Life in Patients With Heart Failure: A Multicenter, Double-Blind, Randomized Controlled Trial

This study is testing if using low-sodium salt can help people with heart failure feel better and stay out of the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1301 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Heart Health Research Center (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06764225 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a low-sodium substitute salt on patients with heart failure. It employs a randomized, double-blind, controlled design, assigning participants to either the low-sodium salt group or a control group using regular salt. Over the course of a year, the study will assess outcomes such as mortality rates, hospital readmissions, emergency visits, and quality of life improvements through questionnaires. The goal is to determine if dietary sodium reduction can lead to better health outcomes for heart failure patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have been hospitalized for heart failure within the past year and have stable heart failure.

Not a fit: Patients with end-stage heart failure or uncontrolled health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a simple dietary intervention that significantly improves health outcomes for heart failure patients.

How similar studies have performed: Other studies have shown promising results with dietary sodium reduction in heart failure management, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18 and 75 years;
2. Hospitalized due to heart failure in the past year;
3. NYHA functional class II-III;
4. Echocardiographic evidence of LVEF \< 40% within the past 6 months;
5. Receiving guideline-directed medical therapy for heart failure;
6. Stable heart failure status, defined as heart failure stability for more than 4 weeks, with no increase in diuretic dose within the past 4 weeks;
7. Having a primary caregiver and frequently dining together at home;
8. Consuming commercially processed food no more than once a week;
9. Providing written informed consent.

Exclusion Criteria:

1. End-stage heart failure;
2. Hospitalization due to cardiovascular causes within the past month;
3. Uncorrected hyponatremia (Na \< 130 mmol/L);
4. Dialysis-dependent patients, or eGFR \< 20 mL/min/1.73m²;
5. Uncontrolled hyperglycemia, with fasting blood glucose \> 16 mmol/L;
6. Malignant cancer patients with a life expectancy of less than 1 year;
7. Conditions that, in the investigator's opinion, may interfere with adherence to the protocol, such as habitual reliance on takeout meals or dining at company cafeterias;
8. Planned hospitalization during the study period;
9. Unexplained weight loss greater than 5 kg in the past year;
10. The subject or family members have concerns about using the salt substitute in this study, or are planning for pregnancy, pregnant, or breastfeeding;
11. Another family member is already participating in this study;
12. The subject or family members are participating in other interventional clinical trials.

Where this trial is running

Beijing, Beijing Municipality

• Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xin Du

Conditions Heart Failure; Dietary Sodium Intake; low-sodium substitute salt