Dataset Information

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.

ABSTRACT:

Background

We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals in high-risk patients with heart failure.

Methods

Of 196 patients with recent (?2 weeks) hospitalization for heart failure, ejection fraction ?40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate. Of these, 27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ?3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15) sodium meals.

Results

On-study retention at 12 weeks was 77% (82% versus 73%; P=0.53); 6 patients (2 in 1500-mg, 4 in 3000-mg arm) withdrew before study completion. Food satisfaction questionnaires indicated that both diets were well tolerated. Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm. Average compliance with meals was 52% (based on urinary sodium) and was not significantly different between arms (42% versus 60%; P=0.25). Study meals reduced 24-hour urinary sodium by 137±21 mmol (1500-mg arm) and 82±16 mmol (3000-mg arm), both P<0.001; between-arms difference was 55 mmol (95% CI, 3-107; P=0.037). NT-proBNP (N-terminal pro-B-type natriuretic peptide) was not affected. Hospitalizations and low blood pressure events did not differ significantly between arms. Serum creatinine decreased more (by 0.17 mg/dL [95% CI, 0.06-0.28]; P=0.003) in the 1500-mg arm. Creatinine increases >0.5 mg/dL over baseline only occurred in 1 patient in the 3000-mg arm.

Conclusions

Even with prepared meals, investigating optimal dietary sodium in heart failure comes with challenges, including need for extensive screening, reluctance to participate, and compliance issues. Because both diets reduced urinary sodium without adverse safety or quality of life signals, a larger trial, with modifications to improve participation and compliance, would be ethical and feasible.

Clinical trial registration

URL: https://www.clinicaltrials.gov. Unique identifier: NCT02467296.

SUBMITTER: Kalogeropoulos A

PROVIDER: S-EPMC7233690 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Kalogeropoulos Andreas A Papadimitriou Lampros L Georgiopoulou Vasiliki V VV Dunbar Sandra B SB Skopicki Hal H Butler Javed J

Circulation. Heart failure 20200121 1

<h4>Background</h4>We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals in high-risk patients with heart failure.<h4>Methods</h4>Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate. Of t ...[more]

PMID: 31959014

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Project description:ObjectivesThis study sought to describe the patterns of heart failure (HF)-exacerbating medications used among older adults hospitalized for HF and to examine determinants of HF-exacerbating medication use.BackgroundHF-exacerbating medications can potentially contribute to adverse outcomes and could represent an important target for future strategies to improve post-hospitalization outcomes.MethodsMedicare beneficiaries ≥65 years of age with an adjudicated HF hospitalization between 2003 and 2014 were derived from the geographically diverse REGARDS (Reasons for Geographic and Racial Difference in Stroke) cohort study. Major HF-exacerbating medications, defined as those listed on the 2016 American Heart Association Scientific Statement listing medications that can precipitate or induce HF, were examined. Patterns of prescribing medications at hospital admission and at discharge were examined, as well as changes that occurred between admission and discharge; and a multivariable logistic regression analysis was conducted to identify determinants of harmful prescribing practices following HF hospitalization (defined as either the continuation of an HF-exacerbating medications or an increase in the number of HF-exacerbating medications between hospital admission and discharge).ResultsAmong 558 unique individuals, 18% experienced a decrease in the number of HF-exacerbating medications between admission and discharge, 19% remained at the same number, and 12% experienced an increase. Multivariable logistic regression analysis revealed that diabetes (odds ratio [OR]: 1.80; 95% confidence interval [CI]: 1.18 to 2.75]) and small hospital size (OR: 1.93; 95% CI: 1.18 to 3.16) were the strongest, independently associated determinants of harmful prescribing practices.ConclusionsHF-exacerbating medication regimens are often continued or started following an HF hospitalization. These findings highlight an ongoing need to develop strategies to improve safe prescribing practices in this vulnerable population.

Project description:Heart failure (HF) is a major public health problem affecting predominantly older adults. Nonadherence to diet remains a significant contributor to acute decompensated HF (ADHF). The sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines. We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and improve health-related quality of life (QOL) in older adults after hospitalization for ADHF.This is a 3-center, randomized, single-blind, controlled trial of 12-week duration designed to determine the safety and efficacy of home-delivered DASH/SRD-compliant meals in older adults after discharge from ADHF hospitalization. Sixty-six subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (<50% vs ?50%). Study subjects will receive either preprepared, home-delivered DASH/SRD-compliant meals or usual dietary advice for 4weeks after hospital discharge. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until study completion. The primary efficacy end point is the change in the Kansas City Cardiomyopathy Questionnaire summary scores for health-related QOL from study enrollment to 4weeks postdischarge. Safety evaluation will focus on hypotension, renal insufficiency, and hyperkalemia. Exploratory end points include echocardiography, noninvasive vascular testing, markers of oxidative stress, and salt taste sensitivity.This randomized controlled trial will test the efficacy, feasibility, and safety of 4weeks of DASH/SRD after ADHF hospitalization. By testing a novel dietary intervention supported by multiple levels of evidence including preliminary data in outpatients with stable HF, we will address a critical evidence gap in the care of older patients with ADHF. If effective and safe, this intervention could be scaled to assess effects on readmission and healthcare costs in older adults after ADHF.

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Dataset Information

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.

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

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.

Similar Datasets

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