Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/24/2018 |
| Start Date: | November 2016 |
| End Date: | July 2020 |
| Contact: | Jennifer Isaacs, MS, MS |
| Email: | jennifer.isaacs@uky.edu |
The Salt Trial: Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
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.
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.
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.
Inclusion Criteria:
- ≥ 18 years of age
- Hospital admission for principal diagnosis of heart failure
- Left ventricular ejection fraction
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
We found this trial at
1
site
740 South Limestone Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Principal Investigator: Maya E Guglin, MD, PhD
Phone: 859-323-4738
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