Heart FailureRESCUE-HFNCT06764225
Effects of Low-Sodium Salt on Death, HF Hospitalization/ Emergency Department Visits and Quality of Life in HF Patients
A study testing low-sodium substitute salt in people with Heart Failure and Dietary Sodium Intake, run by Heart Health Research Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Dietary Sodium Intake
- What is being tested?
- low-sodium substitute salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,301 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Having a primary caregiver and frequently dining together at home;
- Consuming commercially processed food no more than once a week;
- Providing written informed consent.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Xin Du, duxinheart@sina.com
About this study
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
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.
Read the 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
- Being tested
- low-sodium substitute salt
- Keywords
- low-sodium substitute salt
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-sodium substitute saltOther
This study specifically customized sodium reducing substitute salts with a sodium chloride content not exceeding 62% and without the addition of potassium chloride.
| Study group | Role | What they receive |
|---|---|---|
| Low-sodium substitute salt | Experimental | Low-sodium substitute salt Receives: Other: low-sodium substitute salt |
| Regular Salt | No intervention | Regular Salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: From enrollment to the end of follow-up at 1 year
Secondary outcomes (6)
1-year all-cause mortality
Measured: From enrollment to the end of follow-up at 1 year
The number of heart failure hospitalizations/emergency visits within 1 year
Measured: From enrollment to the end of follow-up at 1 year
Time from randomization to the first heart failure hospitalization/emergency visit
Measured: From enrollment to the end of follow-up at 1 year
Cardiovascular mortality within 1 year
Measured: From enrollment to the end of follow-up at 1 year
Change in heart failure quality of life score (KCCQ)
The KCCQ-12 ranges from 0 to 100, where a higher score reflects a better outcome.
Measured: From enrollment to the end of follow-up at 1 year
Change in frailty score for heart failure (FRIED scale)
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.
Measured: From enrollment to the end of follow-up at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start3 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,301 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Health Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764225
- Sponsor's protocol ID
- RESCUE-HF
- Acronym
- RESCUE-HF
- Status last verified
- May 2025
- First submitted
- 24 Dec 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06764225
- Acronym / sponsor ID
- RESCUE-HF / RESCUE-HF
- Conditions
- Heart Failure, Dietary Sodium Intake
- Keywords
- low-sodium substitute salt
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,301 participants (estimated)
- Lead sponsor
- Heart Health Research CenterUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-sodium substitute salt | Experimental | Other: low-sodium substitute saltLow-sodium substitute salt |
| Regular Salt | No intervention | –Regular Salt |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-sodium substitute saltThis study specifically customized sodium reducing substitute salts with a sodium chloride content not exceeding 62% and without the addition of potassium chloride. | Other | Low-sodium substitute salt |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-sodium substitute salt in people with Heart Failure and Dietary Sodium Intake, run by Heart Health Research Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Du (+86-64456862, duxinheart@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.