Heart FailureSALTNCT02689635
Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
A study testing Sodium Restricted Diet and Regular Diet in people with Heart Failure, run by Maya Guglin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sodium Restricted Diet and Regular Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Hospital admission for principal diagnosis of heart failure
- Left ventricular ejection fraction </=40%
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Sodium Restricted Diet, Regular Diet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Restricted DietOther
Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)
Regular DietOther
Non-Cardiac Diet, as defined by our Hospital Nutritional Services
| Study group | Role | What they receive |
|---|---|---|
| Sodium Restricted Diet | Active comparator | Low Salt (cardiac) diet Receives: Other: Sodium Restricted Diet |
| Regular Diet | Active comparator | Non-Cardiac diet Receives: Other: Regular Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission Rate
Number of hospital and ER admissions during the 1 year follow up period
Measured: 12 months
Secondary outcomes (5)
Length of stay
number of days hospitalized
Measured: 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
Measured: 1 year follow up period
Weight
Measured: measured daily during hospital admission period, up to one year
NT-pro BNP, pg/mL
Measured: at the time of hospital admission and time of hospital discharge, up to one year
Diet Satisfaction as assessed by the Diet Acceptability Questionnaire
Measured: at the time of hospital discharge (final hospitalization day, up to one year) and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Why it stopped: PI transferred to a new institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maya Guglin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maya Guglin, Indiana University
- Investigators
- Maya Guglin, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689635
- Sponsor's protocol ID
- 15-0387-F3R
- Acronym
- SALT
- Status last verified
- Oct 2019
- First submitted
- 5 Feb 2016
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Salt Trial: Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
- ClinicalTrials.gov ID
- NCT02689635
- Acronym / sponsor ID
- SALT / 15-0387-F3R
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI transferred to a new institution
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Maya GuglinUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Restricted Diet | Active comparator | Other: Sodium Restricted DietLow Salt (cardiac) diet |
| Regular Diet | Active comparator | Other: Regular DietNon-Cardiac diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Hospital admission for principal diagnosis of heart failure
- Left ventricular ejection fraction </=40%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Restricted DietCardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day) | Other | Sodium Restricted Diet |
| Regular DietNon-Cardiac Diet, as defined by our Hospital Nutritional Services | Other | Regular Diet |
Primary outcome
Readmission Rate
Time frame: 12 months
Number of hospital and ER admissions during the 1 year follow up period
5 secondary outcomes
Length of stay
Time frame: from time of hospital admission to hospital discharge, up to one year
Total length of stay
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
Results and safety
The study was stopped early (reason given: PI transferred to a new institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Guglin, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Restricted Diet and Regular Diet in people with Heart Failure, run by Maya Guglin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI transferred to a new institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.