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Trial record 6 of 88 for:    Recruiting, Not yet recruiting, Available Studies | sodium AND (diet OR dietary)

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

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ClinicalTrials.gov Identifier: NCT02689635
Recruitment Status : Recruiting
First Posted : February 24, 2016
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Maya Guglin, University of Kentucky

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.


Condition or disease Intervention/treatment Phase
Heart Failure Other: Sodium Restricted Diet Other: Regular Diet Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Salt Trial: Low Sodium vs. Regular Diet in Patients Admitted for Heart Failure
Study Start Date : November 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sodium Restricted Diet
Low Salt (cardiac) diet
Other: Sodium Restricted Diet
Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)

Active Comparator: Regular Diet
Non-Cardiac diet
Other: Regular Diet
Non-Cardiac Diet, as defined by our Hospital Nutritional Services




Primary Outcome Measures :
  1. Readmission Rate [ Time Frame: 12 months ]
    Number of hospital and ER admissions during the 1 year follow up period


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: from time of hospital admission to hospital discharge, up to one year ]
    number of days hospitalized

  2. Total length of stay [ Time Frame: 1 year follow up period ]
    total days admitted to hospital during follow up period

  3. Weight [ Time Frame: measured daily during hospital admission period, up to one year ]
  4. NT-pro BNP, pg/mL [ Time Frame: at the time of hospital admission and time of hospital discharge, up to one year ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689635


Contacts
Contact: Jennifer Isaacs, MS, MS jennifer.isaacs@uky.edu

Locations
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Jennifer R Isaacs, MS, MS    859-323-4738    jennifer.isaacs@uky.edu   
Principal Investigator: Maya E Guglin, MD, PhD         
Sponsors and Collaborators
Maya Guglin
Investigators
Principal Investigator: Maya Guglin, MD, PhD University of Kentucky

Responsible Party: Maya Guglin, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02689635     History of Changes
Other Study ID Numbers: 15-0387-F3R
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases