NCT06764225

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,301 (estimated)
• Sponsor: Heart Health Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will involve multiple centers and use a randomized, double-blind, controlled design, where participants will be randomly assigned to either the intervention group (who will use the low-sodium substitute salt ) or the control group (who will use regular salt). Participants will be followed up for at least a year, assessing outcomes including all cause mortality, heart failure hospitalizations, emergency visits, and changes in quality of life as measured by a questionnaire. Eligible participants will be between 18 and 75 years old, have been hospitalized for heart failure in the past year, and have stable heart failure. The study will exclude individuals with severe heart failure, uncontrolled health conditions, or other factors that may interfere with participation. The main goals are to determine if reducing sodium intake through the low-sodium substitute salt leads to better health outcomes in heart failure patients over a year. Participants will be followed up at 3, 6, 9, and 12 months. This research will help provide evidence for whether a simple dietary change, like using a low-sodium substitute salt , can make a meaningful difference in managing heart failure

Conditions

• Heart Failure
• Dietary Sodium Intake

Interventions

Type	Name	Description
OTHER	low-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.

Timeline

• Start date: 2025-04-03
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2025-01-08
• Last updated: 2025-05-21

Locations

1 site across 1 country: China