Clinical trial NCT02689635: Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
Official title: The Salt Trial: Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Readmission Rate
timeFrame: 12 months
Secondary outcomes:
measure: Length of stay
timeFrame: from time of hospital admission to hospital discharge, up to one year
measure: Total length of stay
timeFrame: 1 year follow up period
measure: Weight
timeFrame: measured daily during hospital admission period, up to one year
measure: NT-pro BNP, pg/mL
timeFrame: at the time of hospital admission and time of hospital discharge, up to one year
measure: Diet Satisfaction as assessed by the Diet Acceptability Questionnaire
timeFrame: at the time of hospital discharge (final hospitalization day, up to one year) and one year
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Maya Guglin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: