NCT02689635

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 22, 2021

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

February 5, 2016

Last Update Submit

April 20, 2021

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Readmission Rate

    Number of hospital and ER admissions during the 1 year follow up period

    12 months

Secondary Outcomes (5)

  • Length of stay

    from time of hospital admission to hospital discharge, up to one year

  • Total length of stay

    1 year follow up period

  • Weight

    measured daily during hospital admission period, up to one year

  • NT-pro BNP, pg/mL

    at the time of hospital admission and time of hospital discharge, up to one year

  • Diet Satisfaction as assessed by the Diet Acceptability Questionnaire

    at the time of hospital discharge (final hospitalization day, up to one year) and one year

Study Arms (2)

Sodium Restricted Diet

ACTIVE COMPARATOR

Low Salt (cardiac) diet

Other: Sodium Restricted Diet

Regular Diet

ACTIVE COMPARATOR

Non-Cardiac diet

Other: Regular Diet

Interventions

Sodium Restricted DietOTHER

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

Sodium Restricted Diet
Regular DietOTHER

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

Regular Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Hospital admission for principal diagnosis of heart failure
  • Left ventricular ejection fraction \</=40%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Diet, Sodium-RestrictedDiet

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Maya Guglin, MD, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 24, 2016

Study Start

November 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

April 22, 2021

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)