Effects of Low-Sodium Salt on Death, HF Hospitalization/ Emergency Department Visits and Quality … (NCT06764225) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Low-Sodium Salt on Death, HF Hospitalization/ Emergency Department Visits and Quality of Life in HF Patients
China1,301 participantsStarted 2025-04-03
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: From enrollment to the end of follow-up at 1 year
. Consuming commercially processed food no more than once a week;
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;