Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Location status: Recruiting
NCT Number: NCT06764225
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100029, China
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This study specifically customized sodium reducing substitute salts with a sodium chloride content not exceeding 62% and without the addition of potassium chloride.
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:
Time frame: From enrollment to the end of follow-up at 1 year
Time frame: From enrollment to the end of follow-up at 1 year
Time frame: From enrollment to the end of follow-up at 1 year
Time frame: From enrollment to the end of follow-up at 1 year
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.
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.
Contact information is provided by the study sponsor or research team.
Heart Health Research Center
Other
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
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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