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NCT Number: NCT06764225

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Xin Du

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    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:

    • Death: death is worse than no death; earlier death is worse; tied if not possible to determine.
    • Number of HF hospitalizations/emergency visits,: more HFHs/emergency visits is worse; tied, if same number.
    • Time to first HFH/emergency visit: earlier HFH/emergency visit is worse; tied, if not possible to determine.
    • 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.

Secondary outcomes

  1. 1-year all-cause mortality

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

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

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

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

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

  4. Cardiovascular mortality within 1 year

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

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Heart Health Research Center

Other

Collaborators

  • Beijing Anzhen Hospital

Registry information

Official study 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

Acronym: RESCUE-HF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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