Dietary Sodium Intake and Outcomes in Heart Failure (PROHIBITSodium)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary plan with controlled amount of Sodium
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring Sodium, outcomes
Eligibility Criteria
Inclusion Criteria:
- Age ≥21 years at screening
- Recent (≤1 year) EF ≤40%
- Standard HF treatment, including ACEI/ARB & beta-blockers & aldosterone antagonists, unless contraindicated or intolerant
5. Able to consume research diet (e.g. no dysphagia etc.) 6. Systolic blood pressure ≥100 mmHg 7. >3000 mg/d sodium excretion (by 24-hr urinary sodium)
Exclusion Criteria:
- Institutionalized patients
- Siogns or symptoms of instability in HF status
- Communication barriers, including cognitive impairment; inability to communicate and understand and cooperate with the protocol
- Severe non-cardiac illness that compromises life expectancy within the next 12 months or the ability to participate in the study (e.g. severe hepatobiliary disease, cancer underground chemo- or radiotherapy)
- Any medical or surgical procedure planned in the next 6 months
- Participants planning to move to a different state within 6 months
- Participation in any other experimental protocol
- Renal replacement therapy or Stage 4 or 5 chronic kidney disease
Sites / Locations
- Stony Brook University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A: 1.5 gr of Sodium
B: 3 gr of Sodium
Arm Description
Meal Plans with 1.5 gr of Sodium
Meal Plans with 3 gr of Sodium
Outcomes
Primary Outcome Measures
Patient On-Study Retention
Percentage of patients retained in the study
Secondary Outcome Measures
All cause mortality
Percentage of patients died
Rehospitalization
Percentage of patients rehospitalized
Emergency room visits
Percentage of patients visited emergency room
NT-proBNP
Concentration in pg/ml
Kansas City Cardiomyopathy Questionnaire
The 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) measures health status in patients with heart failure (HF),
KCCQ has 6 domains and 2 summary scores:
Symptom Domain: frequency and burden of symptoms. Physical Function Domain: limitations. Quality of Life (QoL) Domain: reflects QoL Social Limitation Domain: ability to interact in social activities. Self-efficacy Domain: patients' perceptions of how to prevent HF exacerbations. Symptom Stability Domain: recent changes in symptoms. Clinical Summary Score includes total symptom and physical function. Overall Summary Score includes the total symptom, physical function, social limitations and QoL scores.
The KCCQ is scored by assigning each response an ordinal value, beginning with 1. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. Best is 100.
Food Palatability Questionnaire
Likert Scales for appearance, taste, and quantity of food (from 1 to 5 - 5 being the most acceptable)
Full Information
NCT ID
NCT02467296
First Posted
June 3, 2015
Last Updated
September 23, 2019
Sponsor
Stony Brook University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02467296
Brief Title
Dietary Sodium Intake and Outcomes in Heart Failure
Acronym
PROHIBITSodium
Official Title
Rationale and Design of the PRevent Adverse Outcomes in Heart faIlure By limITing Sodium Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Currently, the recommendations for sodium intake restriction for patients with heart failure are mostly based on expert consensus and observational evidence, whereas smaller randomized studies have actually suggested that strict dietary sodium reduction may be harmful in heart failure. In the present clinical trial pilot study, the investigators plan to collect data on enrollment rates, compliance, outcomes, and safety of a 12-week dietary intervention in heart failure patients, with prepared food containing two different levels of sodium (1,500 mg and 3,000 mg) daily, followed by a 12-week surveillance for safety and effectiveness. The goal is to inform the design of a fullscale clinical trial that will provide more definitive evidence for dietary sodium recommendations in heart failure.
Detailed Description
Despite the intense research for improving outcomes in heart failure, evidence remains scarce (and mostly observational) for dietary sodium restriction, arguably the most widely recommended self-care measure for heart failure. In explicit acknowledgement of the evidence gaps and unclear benefits, the recent European Society of Cardiology guidelines have not assigned a level of evidence to sodium intake recommendations and the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines do not provide a specific target level of sodium intake for patients with HF.
Although it seems reasonable to restrict sodium below <3000 mg/d in heart failure, it is currently unknown how "low" is appropriate for these patients.
This study will attempt to provide the basis to evaluate the above guidelines by determining, in consecutive HFrEF patients with EF ≤40% during an acute HF admission, the proportion of patients who: (1) are willing to participate in a 12-week feeding trial; (2) meet the trial eligibility criteria; and (C) subsequently continue to consume ≥3000 mg/d sodium 15-30 days post discharge despite discharge instructions. This will allow the investigators to estimate enrollment rates in a full-scale trial.
This study will randomize 50 eligible patients to prepared meal plans with either 1500 mg/d vs. 3000 mg/d sodium for 12 weeks .
The hypotheses of the present study are that (1) ≥ 90% of patients will be retained on the study by 12 weeks (or at first outcome or safety event) and (2) patients will be compliant with provided food ≥ 90% of the study days.
Study Primary Endpoints:
(i) Overall on-study retention and (ii) compliance with the prepared food, assessed via daily food diaries and 24-h urine collections at baseline, 4, 8, and 12 weeks.
Study Secondary Endpoints:
Estimate trends in (1) all-cause mortality, readmissions, and emergency room visits; (2) NT-pro-B-type natriuretic peptide levels; and (3) diet palatability and quality of life, between the two arms.
Safety endpoints:
Safety of the intervention assessed by vital sign and laboratory assessments. This pilot study is expected to yield critical information necessary and sufficient to design a full-scale clinical trial that will provide evidence for dietary sodium recommendations in heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Sodium, outcomes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: 1.5 gr of Sodium
Arm Type
Active Comparator
Arm Description
Meal Plans with 1.5 gr of Sodium
Arm Title
B: 3 gr of Sodium
Arm Type
Active Comparator
Arm Description
Meal Plans with 3 gr of Sodium
Intervention Type
Other
Intervention Name(s)
Dietary plan with controlled amount of Sodium
Intervention Description
Dietary plan with 1.5 gr vs 3 gr of Sodium
Primary Outcome Measure Information:
Title
Patient On-Study Retention
Description
Percentage of patients retained in the study
Time Frame
3 month meal plan
Secondary Outcome Measure Information:
Title
All cause mortality
Description
Percentage of patients died
Time Frame
6 months follow up period
Title
Rehospitalization
Description
Percentage of patients rehospitalized
Time Frame
6 months follow up period
Title
Emergency room visits
Description
Percentage of patients visited emergency room
Time Frame
6 months follow up period
Title
NT-proBNP
Description
Concentration in pg/ml
Time Frame
6months follow up period
Title
Kansas City Cardiomyopathy Questionnaire
Description
The 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) measures health status in patients with heart failure (HF),
KCCQ has 6 domains and 2 summary scores:
Symptom Domain: frequency and burden of symptoms. Physical Function Domain: limitations. Quality of Life (QoL) Domain: reflects QoL Social Limitation Domain: ability to interact in social activities. Self-efficacy Domain: patients' perceptions of how to prevent HF exacerbations. Symptom Stability Domain: recent changes in symptoms. Clinical Summary Score includes total symptom and physical function. Overall Summary Score includes the total symptom, physical function, social limitations and QoL scores.
The KCCQ is scored by assigning each response an ordinal value, beginning with 1. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. Best is 100.
Time Frame
6 months follow up period
Title
Food Palatability Questionnaire
Description
Likert Scales for appearance, taste, and quantity of food (from 1 to 5 - 5 being the most acceptable)
Time Frame
6 months follow up period
Other Pre-specified Outcome Measures:
Title
Systolic Blood Pressure
Description
'mmHg'
Time Frame
6 month follow up
Title
Creatinine
Description
'mg/dl'
Time Frame
6 month follow up
Title
Blood Urea Nitrogen
Description
'mg/dl'
Time Frame
6 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥21 years at screening
Recent (≤1 year) EF ≤40%
Standard HF treatment, including ACEI/ARB & beta-blockers & aldosterone antagonists, unless contraindicated or intolerant
5. Able to consume research diet (e.g. no dysphagia etc.) 6. Systolic blood pressure ≥100 mmHg 7. >3000 mg/d sodium excretion (by 24-hr urinary sodium)
Exclusion Criteria:
Institutionalized patients
Siogns or symptoms of instability in HF status
Communication barriers, including cognitive impairment; inability to communicate and understand and cooperate with the protocol
Severe non-cardiac illness that compromises life expectancy within the next 12 months or the ability to participate in the study (e.g. severe hepatobiliary disease, cancer underground chemo- or radiotherapy)
Any medical or surgical procedure planned in the next 6 months
Participants planning to move to a different state within 6 months
Participation in any other experimental protocol
Renal replacement therapy or Stage 4 or 5 chronic kidney disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javed Butler, MD, MPH, MBA
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31959014
Citation
Kalogeropoulos A, Papadimitriou L, Georgiopoulou VV, Dunbar SB, Skopicki H, Butler J. Low- Versus Moderate-Sodium Diet in Patients With Recent Hospitalization for Heart Failure: The PROHIBIT (Prevent Adverse Outcomes in Heart Failure by Limiting Sodium) Pilot Study. Circ Heart Fail. 2020 Jan;13(1):e006389. doi: 10.1161/CIRCHEARTFAILURE.119.006389. Epub 2020 Jan 21.
Results Reference
derived
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Dietary Sodium Intake and Outcomes in Heart Failure
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