Heart FailurePROHIBITSodiumNCT02467296
Dietary Sodium Intake and Outcomes in Heart Failure
A study of Heart Failure, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rationale and Design of the PRevent Adverse Outcomes in Heart faIlure By limITing Sodium Study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Dietary plan with controlled amount of Sodium
- Keywords
- Sodium, outcomes
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary plan with controlled amount of SodiumOther
Dietary plan with 1.5 gr vs 3 gr of Sodium
| Study group | Role | What they receive |
|---|---|---|
| A: 1.5 gr of Sodium | Active comparator | Meal Plans with 1.5 gr of Sodium Receives: Other: Dietary plan with controlled amount of Sodium |
| B: 3 gr of Sodium | Active comparator | Meal Plans with 3 gr of Sodium Receives: Other: Dietary plan with controlled amount of Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient On-Study Retention
Percentage of patients retained in the study
Measured: 3 month meal plan
Secondary outcomes (6)
All cause mortality
Percentage of patients died
Measured: 6 months follow up period
Rehospitalization
Percentage of patients rehospitalized
Measured: 6 months follow up period
Emergency room visits
Percentage of patients visited emergency room
Measured: 6 months follow up period
NT-proBNP
Concentration in pg/ml
Measured: 6months follow up period
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.
Measured: 6 months follow up period
Food Palatability Questionnaire
Likert Scales for appearance, taste, and quantity of food (from 1 to 5 - 5 being the most acceptable)
Measured: 6 months follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Javed Butler, Stony Brook University
- Investigators
- Javed Butler, MD, MPH, MBA, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467296
- Sponsor's protocol ID
- 1R34HL119773
- Other IDs
- 639316, R34HL119773
- Acronym
- PROHIBITSodium
- Status last verified
- Sep 2019
- First submitted
- 3 Jun 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31959014
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale and Design of the PRevent Adverse Outcomes in Heart faIlure By limITing Sodium Study
- ClinicalTrials.gov ID
- NCT02467296
- Acronym / sponsor ID
- PROHIBITSodium / 1R34HL119773
- Conditions
- Heart Failure
- Keywords
- Sodium, outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: 1.5 gr of Sodium | Active comparator | Other: Dietary plan with controlled amount of SodiumMeal Plans with 1.5 gr of Sodium |
| B: 3 gr of Sodium | Active comparator | Other: Dietary plan with controlled amount of SodiumMeal Plans with 3 gr of Sodium |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary plan with controlled amount of SodiumDietary plan with 1.5 gr vs 3 gr of Sodium | Other | A: 1.5 gr of Sodium, B: 3 gr of Sodium |
Primary outcome
Patient On-Study Retention
Time frame: 3 month meal plan
Percentage of patients retained in the study
6 secondary outcomes
All cause mortality
Time frame: 6 months follow up period
Rehospitalization
Time frame: 6 months follow up period
Emergency room visits
Time frame: 6 months follow up period
NT-proBNP
Time frame: 6months follow up period
Kansas City Cardiomyopathy Questionnaire
Time frame: 6 months follow up period
Food Palatability Questionnaire
Time frame: 6 months follow up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 31959014Kalogeropoulos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javed Butler, MD, MPH, MBA principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Heart Failure, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient On-Study Retention (time frame: 3 month meal plan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.