Using low-sodium salt to improve heart failure outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a low-sodium substitute salt on patients with heart failure. It employs a randomized, double-blind, controlled design, assigning participants to either the low-sodium salt group or a control group using regular salt. Over the course of a year, the study will assess outcomes such as mortality rates, hospital readmissions, emergency visits, and quality of life improvements through questionnaires. The goal is to determine if dietary sodium reduction can lead to better health outcomes for heart failure patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged between 18 and 75 years;
2. Hospitalized due to heart failure in the past year;
3. NYHA functional class II-III;
4. Echocardiographic evidence of LVEF \< 40% within the past 6 months;
5. Receiving guideline-directed medical therapy for heart failure;
6. 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;
7. Having a primary caregiver and frequently dining together at home;
8. Consuming commercially processed food no more than once a week;
9. Providing written informed consent.

Exclusion Criteria:

1. End-stage heart failure;
2. Hospitalization due to cardiovascular causes within the past month;
3. Uncorrected hyponatremia (Na \< 130 mmol/L);
4. Dialysis-dependent patients, or eGFR \< 20 mL/min/1.73m²;
5. Uncontrolled hyperglycemia, with fasting blood glucose \> 16 mmol/L;
6. Malignant cancer patients with a life expectancy of less than 1 year;
7. 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;
8. Planned hospitalization during the study period;
9. Unexplained weight loss greater than 5 kg in the past year;
10. The subject or family members have concerns about using the salt substitute in this study, or are planning for pregnancy, pregnant, or breastfeeding;
11. Another family member is already participating in this study;
12. The subject or family members are participating in other interventional clinical trials.

Where it's running

• Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xin Du
• Email: duxinheart@sina.com
• Phone: +86-64456862

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.