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

May 16, 2025 updated by: Heart Health Research Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

1301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Anzhen Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-sodium substitute salt
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.
No Intervention: Regular Salt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year all-cause mortality
Time Frame: From enrollment to the end of follow-up at 1 year
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
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
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
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
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
Change in frailty score for heart failure (FRIED scale)
Time Frame: From enrollment to the end of follow-up at 1 year
The FRIED scale assesses frailty in older adults based on five criteria: weight loss, exhaustion, weakness, slowness, and low activity. Frailty is classified as non-frail (0), pre-frail (1-2), or frail (≥3), predicting risks like falls, hospitalization, and mortality.
From enrollment to the end of follow-up at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Health Research Center

Collaborators

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

January 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCUE-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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