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

Heart Failure Clinical Trial

— SALT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02689635
• Other study ID #: 15-0387-F3R
• Status: Terminated
• Phase: N/A
• Start date: November 2016
• Est. completion date: February 2019

Study information

• Verified date: October 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Sodium Restricted Diet
Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)
• Regular Diet
Non-Cardiac Diet, as defined by our Hospital Nutritional Services

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Maya Guglin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission Rate	Number of hospital and ER admissions during the 1 year follow up period	12 months
Secondary	Length of stay	number of days hospitalized	from time of hospital admission to hospital discharge, up to one year
Secondary	Total length of stay	total days admitted to hospital during follow up period	1 year follow up period
Secondary	Weight		measured daily during hospital admission period, up to one year
Secondary	NT-pro BNP, pg/mL		at the time of hospital admission and time of hospital discharge, up to one year
Secondary	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