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Dietary Sodium Intake and Outcomes in Heart Failure (PROHIBITSodium)

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ClinicalTrials.gov Identifier: NCT02467296
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Javed Butler, Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Dietary plan with controlled amount of Sodium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Rationale and Design of the PRevent Adverse Outcomes in Heart faIlure By limITing Sodium Study
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A: 1.5 gr of Sodium
Meal Plans with 1.5 gr of Sodium
Other: Dietary plan with controlled amount of Sodium
Dietary plan with 1.5 gr vs 3 gr of Sodium

Active Comparator: B: 3 gr of Sodium
Meal Plans with 3 gr of Sodium
Other: Dietary plan with controlled amount of Sodium
Dietary plan with 1.5 gr vs 3 gr of Sodium




Primary Outcome Measures :
  1. Patient On-Study Retention [ Time Frame: 3 month meal plan ]
    Percentage of patients retained in the study


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 6 months follow up period ]
    Percentage of patients died

  2. Rehospitalization [ Time Frame: 6 months follow up period ]
    Percentage of patients rehospitalized

  3. Emergency room visits [ Time Frame: 6 months follow up period ]
    Percentage of patients visited emergency room

  4. NT-proBNP [ Time Frame: 6months follow up period ]
    Concentration in pg/ml

  5. Kansas City Cardiomyopathy Questionnaire [ Time Frame: 6 months follow up period ]

    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.


  6. Food Palatability Questionnaire [ Time Frame: 6 months follow up period ]
    Likert Scales for appearance, taste, and quantity of food (from 1 to 5 - 5 being the most acceptable)


Other Outcome Measures:
  1. Systolic Blood Pressure [ Time Frame: 6 month follow up ]
    'mmHg'

  2. Creatinine [ Time Frame: 6 month follow up ]
    'mg/dl'

  3. Blood Urea Nitrogen [ Time Frame: 6 month follow up ]
    'mg/dl'



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥21 years at screening
  2. Recent (≤1 year) EF ≤40%
  3. 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:

  1. Institutionalized patients
  2. Siogns or symptoms of instability in HF status
  3. Communication barriers, including cognitive impairment; inability to communicate and understand and cooperate with the protocol
  4. 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)
  5. Any medical or surgical procedure planned in the next 6 months
  6. Participants planning to move to a different state within 6 months
  7. Participation in any other experimental protocol
  8. Renal replacement therapy or Stage 4 or 5 chronic kidney disease

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): NCT02467296


Locations
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United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Javed Butler, MD, MPH, MBA Stony Brook University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Javed Butler, MD, MPH, MBA, Stony Brook University
ClinicalTrials.gov Identifier: NCT02467296    
Other Study ID Numbers: 1R34HL119773 ( U.S. NIH Grant/Contract )
639316 ( Other Identifier: Stony Brook CORIHS A )
R34HL119773 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Javed Butler, Stony Brook University:
Sodium
outcomes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases