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

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Other: Sodium Restricted Diet; Other: Regular Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maya Guglin
• Investigators: Principal Investigator: Maya Guglin, MD, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 15-0387-F3R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No