Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: Regular DietOther: Sodium Restricted Diet
- Registration Number
- NCT02689635
- Lead Sponsor
- Maya Guglin
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
- ≥ 18 years of age
- Hospital admission for principal diagnosis of heart failure
- Left ventricular ejection fraction </=40%
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regular Diet Regular Diet Non-Cardiac diet Sodium Restricted Diet Sodium Restricted Diet Low Salt (cardiac) diet
- Primary Outcome Measures
Name Time Method Readmission Rate 12 months Number of hospital and ER admissions during the 1 year follow up period
- Secondary Outcome Measures
Name Time Method Total length of stay 1 year follow up period total days admitted to hospital during follow up period
Length of stay from time of hospital admission to hospital discharge, up to one year number of days hospitalized
NT-pro BNP, pg/mL at the time of hospital admission and time of hospital discharge, up to one year Weight measured daily during hospital admission period, 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
Trial Locations
- Locations (1)
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States