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

NCT ID: NCT02689635

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sodium Restricted Diet

Low Salt (cardiac) diet

Group Type: ACTIVE_COMPARATOR

Sodium Restricted Diet

Intervention Type: OTHER

Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)

Regular Diet

Non-Cardiac diet

Group Type: ACTIVE_COMPARATOR

Regular Diet

Intervention Type: OTHER

Non-Cardiac Diet, as defined by our Hospital Nutritional Services

Interventions

Sodium Restricted Diet

Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)

Intervention Type: OTHER

Regular Diet

Non-Cardiac Diet, as defined by our Hospital Nutritional Services

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maya Guglin

OTHER

Sponsor Role: lead

Responsible Party

Maya Guglin

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maya Guglin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky Medical Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

15-0387-F3R

Identifier Type: -

Identifier Source: org_study_id