Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure (SALT)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium Restricted Diet
Regular Diet
Sponsored by

About this trial
This is an interventional prevention trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- University of Kentucky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sodium Restricted Diet
Regular Diet
Arm Description
Low Salt (cardiac) diet
Non-Cardiac diet
Outcomes
Primary Outcome Measures
Readmission Rate
Number of hospital and ER admissions during the 1 year follow up period
Secondary Outcome Measures
Length of stay
number of days hospitalized
Total length of stay
total days admitted to hospital during follow up period
Weight
NT-pro BNP, pg/mL
Diet Satisfaction as assessed by the Diet Acceptability Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02689635
Brief Title
Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
Acronym
SALT
Official Title
The Salt Trial: Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
PI transferred to a new institution
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maya Guglin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Restricted Diet
Arm Type
Active Comparator
Arm Description
Low Salt (cardiac) diet
Arm Title
Regular Diet
Arm Type
Active Comparator
Arm Description
Non-Cardiac diet
Intervention Type
Other
Intervention Name(s)
Sodium Restricted Diet
Intervention Description
Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)
Intervention Type
Other
Intervention Name(s)
Regular Diet
Intervention Description
Non-Cardiac Diet, as defined by our Hospital Nutritional Services
Primary Outcome Measure Information:
Title
Readmission Rate
Description
Number of hospital and ER admissions during the 1 year follow up period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Length of stay
Description
number of days hospitalized
Time Frame
from time of hospital admission to hospital discharge, up to one year
Title
Total length of stay
Description
total days admitted to hospital during follow up period
Time Frame
1 year follow up period
Title
Weight
Time Frame
measured daily during hospital admission period, up to one year
Title
NT-pro BNP, pg/mL
Time Frame
at the time of hospital admission and time of hospital discharge, up to one year
Title
Diet Satisfaction as assessed by the Diet Acceptability Questionnaire
Time Frame
at the time of hospital discharge (final hospitalization day, up to one year) and one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Guglin, MD, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
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