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

NCT06764225 | Recruiting DMC

• 1 other identifier: RESCUE-HF
• Study Type: interventional
• Target: 1,301
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Dietary Sodium Intake

Keywords

low-sodium substitute salt

Outcome Measures

Primary Outcomes (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

  Clinical benefit, a composite of all cause death, the number of HFHs/emergency visits, time to the first HFH/emergency visit, and the change in quality of life (Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) )at 1 year. All patients randomized to low-sodium group are compared to those randomized to control group within strata. For any two patients, a patient will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an advantage for either patient is shown: 1. Death: death is worse than no death; earlier death is worse; tied if not possible to determine. 2. Number of HF hospitalizations/emergency visits,: more HFHs/emergency visits is worse; tied, if same number. 3. Time to first HFH/emergency visit: earlier HFH/emergency visit is worse; tied, if not possible to determine. 4. KCCQ-12 at 1 year: Higher KCCQ-12 is better. The KCCQ-12 ranges from 0 to 100, where a higher score reflects a better outcome.

  From enrollment to the end of follow-up at 1 year

Secondary Outcomes (6)

• 1-year all-cause mortality

  From enrollment to the end of follow-up at 1 year

• The number of heart failure hospitalizations/emergency visits within 1 year

  From enrollment to the end of follow-up at 1 year

• Time from randomization to the first heart failure hospitalization/emergency visit

  From enrollment to the end of follow-up at 1 year

• Cardiovascular mortality within 1 year

  From enrollment to the end of follow-up at 1 year

• Change in heart failure quality of life score (KCCQ)

  From enrollment to the end of follow-up at 1 year

Study Arms (2)

Low-sodium substitute salt

EXPERIMENTAL

Low-sodium substitute salt

Other: low-sodium substitute salt

Regular Salt

NO INTERVENTION

Regular Salt

Interventions

low-sodium substitute salt OTHER

This study specifically customized sodium reducing substitute salts with a sodium chloride content not exceeding 62% and without the addition of potassium chloride.

Low-sodium substitute salt

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Health Research Center: lead
• Beijing Anzhen Hospital: collaborator

Study Sites (1)

Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xin Du

CONTACT

+86-64456862; duxinheart@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 8, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (1)