RecruitingNot ApplicableNCT06764225

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

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

Sponsor

Heart Health Research Center

Enrollment

1,301 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure Dietary Sodium Intake

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

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;
Receiving guideline-directed medical therapy for heart failure;
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;
Having a primary caregiver and frequently dining together at home;
Consuming commercially processed food no more than once a week;
Providing written informed consent.

Exclusion Criteria12

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;
Uncontrolled hyperglycemia, with fasting blood glucose \> 16 mmol/L;
Malignant cancer patients with a life expectancy of less than 1 year;
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;
Planned hospitalization during the study period;
Unexplained weight loss greater than 5 kg in the past year;
The subject or family members have concerns about using the salt substitute in this study, or are planning for pregnancy, pregnant, or breastfeeding;
Another family member is already participating in this study;
The subject or family members are participating in other interventional clinical trials.

Interventions

OTHERlow-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.