NCT06764225Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1301 (estimated)
- First submitted
- 24 Dec 2024
- Start date
- 3 Apr 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Heart Health Research Center
- Diseases
- Heart failure
- NCT number
- NCT06764225
What you commit to
- Study type: Interventional
- Planned participants: 1301
- From 3 Apr 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- End-stage heart failure;
- 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;
Lab values
- 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;
Other
- Hospitalization due to cardiovascular causes within the past month;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.