Effects of Low-Sodium Salt on Death, HF Hospitalization/ Emergency Department Visits and Quality of Life in HF Patients

Official title

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

Overview

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

Interventions

• 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.

Primary outcome measures

• 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 [Time frame: From enrollment to the end of follow-up at 1 year]

Secondary outcome measures (6)

• 1-year all-cause mortality [Time frame: From enrollment to the end of follow-up at 1 year]
• The number of heart failure hospitalizations/emergency visits within 1 year [Time frame: From enrollment to the end of follow-up at 1 year]
• Time from randomization to the first heart failure hospitalization/emergency visit [Time frame: From enrollment to the end of follow-up at 1 year]
• Cardiovascular mortality within 1 year [Time frame: From enrollment to the end of follow-up at 1 year]
• Change in heart failure quality of life score (KCCQ) [Time frame: From enrollment to the end of follow-up at 1 year]
• Change in frailty score for heart failure (FRIED scale) [Time frame: From enrollment to the end of follow-up at 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Anzhen Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06764225 · RESCUE-HF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗