Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure

Study Overview
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Brief Summary
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Patients over 18 years of age, admitted to the hospital with HF exacerbation, will be eligible for randomization to low salt or regular diet. Laboratory tests are routinely obtained on admission and on the day (or the day before) of discharge (comprehensive metabolic panel and NT-proBNP) and will be recorded for the study. Daily weights are routinely recorded, and intake/output will be monitored. At discharge, a Diet Acceptability Questionnaire will be performed. After the discharge, participants will return for follow-up visits as needed for clinical indications. Our study coordinator will document changes of symptoms, changes in therapies, and capture clinical events like unscheduled hospital visits or visits to the Emergency Room. Once during the study patients will be asked about their specific food consumption on a prior day, and the Sodium content will be estimated. The final visit will occur in a year (approximately 11-13 months after enrollment). Weight, other vital signs, CMP, BNP, and Diet Acceptability Questionnaire quality of life questionnaire will be collected at this point, if clinically indicated. The majority of study information will be collected from routine care for standard clinical indications. The only components added for study purpose are Diet Acceptability Questionnaire and collection of the information on consumed foods.

Detailed Description
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This study will include patients over 18 years of age, admitted to the hospital with HF exacerbation, will be eligible for randomization to low salt or regular diet. Laboratory tests are routinely obtained on admission and on the day (or the day before) of discharge (comprehensive metabolic panel and NT-proBNP) and will be recorded for the study. Daily weights are routinely recorded, and intake/output will be monitored. At discharge, a Diet Acceptability Questionnaire will be performed. After the discharge, participants will return for follow-up visits as needed for clinical indications. Our study coordinator will document changes of symptoms, changes in therapies, and capture clinical events like unscheduled hospital visits or visits to the Emergency Room. Once during the study patients will be asked about their specific food consumption on a prior day, and the Sodium content will be estimated. The final visit will occur in a year (approximately 11-13 months after enrollment). Weight, other vital signs, CMP, BNP, and Diet Acceptability Questionnaire quality of life questionnaire will be collected at this point, if clinically indicated. The majority of study information will be collected from routine care for standard clinical indications. The only components added for study purpose are Diet Acceptability Questionnaire and collection of the information on consumed foods.The number of total days in the hospital for heart failure throughout the year will be compared between the arms.

Official Title
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The Salt Trial: Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Sodium Restricted Diet
* Other: Regular Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Hospital admission for principal diagnosis of heart failure Left ventricular ejection fraction </=40% Exclusion Criteria: Concomitant hypertension (blood pressure >150/90 mmHg on admission and at least twice more during the index stay) Planned LVAD or Heart Transplant in next 3 months Patient on current or planned renal dialysis Inability to give the consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Restricted Diet<br>Low Salt (cardiac) diet | Other: Sodium Restricted Diet<br>* Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)<br>|
| Active Comparator: Regular Diet<br>Non-Cardiac diet | Other: Regular Diet<br>* Non-Cardiac Diet, as defined by our Hospital Nutritional Services<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission Rate | Number of hospital and ER admissions during the 1 year follow up period | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | number of days hospitalized | from time of hospital admission to hospital discharge, up to one year | 
| Total length of stay | total days admitted to hospital during follow up period | 1 year follow up period | 
| Weight |  | measured daily during hospital admission period, up to one year | 
| NT-pro BNP, pg/mL |  | at the time of hospital admission and time of hospital discharge, up to one year | 
| Diet Satisfaction as assessed by the Diet Acceptability Questionnaire |  | at the time of hospital discharge (final hospitalization day, up to one year) and one year |