An interventional study of Sodium Restricted Diet and Regular Diet in Heart Failure, sponsored by Maya Guglin. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Maya Guglin · Not applicable, Interventional, and Prevention
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.
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.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 13 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Maya Guglin is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low Salt (cardiac) diet
Other: Sodium Restricted Diet
Non-Cardiac diet
Other: Regular Diet
Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)
Non-Cardiac Diet, as defined by our Hospital Nutritional Services
Readmission Rate
Number of hospital and ER admissions during the 1 year follow up period
Time frame: 12 months
Length of stay
number of days hospitalized
Time frame: 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
Time frame: 1 year follow up period
Weight
Time frame: measured daily during hospital admission period, up to one year
NT-pro BNP, pg/mL
Time frame: at the time of hospital admission and time of hospital discharge, up to one year
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
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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