Effects of Low-Sodium Salt on Death, HF Hospitalization/ Emergency Department Visits and Quality of Life in HF Patients

ConditionsHeart Failure Dietary Sodium Intake

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorHeart Health Research Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 75 years;

Hospitalized due to heart failure in the past year;

NYHA functional class II-III;

Echocardiographic evidence of LVEF < 40% within the past 6 months;

Disqualifiers

End-stage heart failure;

Hospitalization due to cardiovascular causes within the past month;

Uncorrected hyponatremia (Na < 130 mmol/L);

Dialysis-dependent patients, or eGFR < 20 mL/min/1.73m²;

Trial design

Design model

Parallel

Treatments tested in this trial

low-sodium substitute salt
Other intervention
This study specifically customized sodium reducing substitute salts with a sodium chloride content not exceeding 62% and without the addition of potassium chloride.

Treatment groups

1,301 Participants

are divided into 2 treatment groups

Group A: Low-sodium substitute saltExperimental treatment 1 intervention

Group B: Regular SaltNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

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.

Time frame