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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-sodium substitute salt | Experimental | Low-sodium substitute salt |
|
| Regular Salt | No Intervention | Regular Salt |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 | 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:
| From enrollment to the end of follow-up at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Du | Contact | +86-64456862 | duxinheart@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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) | 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) | 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 |