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

M

Maya Guglin

Status

Terminated

Conditions

Heart Failure

Treatments

Other: Regular Diet
Other: Sodium Restricted Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02689635
15-0387-F3R

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

13 participants in 2 patient groups

Sodium Restricted Diet
Active Comparator group
Description:
Low Salt (cardiac) diet
Treatment:
Other: Sodium Restricted Diet
Regular Diet
Active Comparator group
Description:
Non-Cardiac diet
Treatment:
Other: Regular Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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