low-sodium substitute salt: This study specifically customized sodium reducing substitute salts with a sodium chloride content not exceeding 62% and without the addition of potassium chloride.
Study summary
This study aims to investigate whether using a low-sodium substitute salt can help improve outcomes for patients with heart failure. Specifically, it will examine if the low-sodium substitute salt can reduce death rates, hospital readmissions, and emergency visits, as well as improve the quality of life for these patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Percentage of pairwise comparisons with wins of a composite endpoint including 1-year death, the number of HF hospitalizations/emergency visits, time to the first HF hospitalization/emergency visit, and the change in quality of life at 12 months — From enrollment to the end of follow-up at 1 year Clinical benefit, a composite of all cause death, the number of HFHs/emergency visits, time to the first HFH/emergency visit, and the change in quality of life (Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) )at 1 year. All patients randomized to low-sodium group are compared to those randomized to control group within strata. For any two patients, a patient will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an advantage for either patient is shown:
1. Death: death is worse than no death; earlier death is worse; tied if not possible to determine.
2. Number of HF hospitalizations/emergency visits,: more HFHs/emergency visits is worse; tied, if same number.
3. Time to first HFH/emergency visit: earlier HFH/emergency visit is worse; tied, if not possible to determine.
4. KCCQ-12 at 1 year: Higher KCCQ-12 is better. The KCCQ-12 ranges from 0 to 100, where a higher score reflects a better outcome.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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