Effects of Low-Sodium Salt on Death, HF Hospitalization/ Emergency Department Visits and Quality of Life in HF Patients
Recruiting · NCT06764225 · Interventional (participants receive a specific treatment) · Lead sponsor: Heart Health Research Center
View the official record on ClinicalTrials.gov →Interventions studied
low-sodium substitute salt
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Anzhen Hospital, Capital Medical University - Beijing, Beijing Municipality, China