The long-term effects of dietary sodium restriction on clinical outcomes in patients with heart failure. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure): A pilot study

Colin-Ramírez, Eloisa; McAlister, Finlay A.; Zheng, Yinggan; Sharma, Sangita; Armstrong, Paul W.; Ezekowitz, Justin A.

doi:10.1016/j.ahj.2014.11.013

Cited by 58 publications

(60 citation statements)

References 35 publications

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“…Previous studies and the ongoing Geriatric Out-of-Hospital Randomized Meal Trial in Heart Failure (GOURMET-HF) study applied the KCCQ summary score as an indicator of QoL outcome and drew the same conclusion as that in our study [23][24][25]. Regarding PHYS, the reason for the increase may be that an LSD improved symptoms and signs of CHF [26,27] and promoted exercise tolerance in patients [27].…”

Section: Mcid and Its Interpretation To The Multilevel Modelsupporting

confidence: 62%

Assessment of Chronic Disease Self-management in Patients With Chronic Heart Failure Based on the MCID of Patient-reported Outcomes by the Multilevel Model

Tian

Zhao

Zhang

et al. 2020

Preprint

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Abstract Purpose:The minimal clinically important difference (MCID) of a patient-reported outcome (PRO) represents the threshold value of the change in the score for that PRO. It is deemed to have an important implication in clinical management. This study was performed to evaluate the clinical significance of chronic disease self-management (CDSM) for patients with chronic heart failure based on the MCID of the chronic heart failure - PRO measure (CHF-PROM).Methods: A multicenter, prospective cohort study of 555 patients with heart failure were enrolled from May 2017 to May 2019. Advice of CDSM was provided in written form at discharge to all patients. Information regarding CHF-PROM and CDSM were collected during follow-up. Multilevel models were applied to dynamically evaluate the effects of CDSM for CHF-PROM scores, as well as its physical and psychological domains. MCID changes of the PRO were introduced and compared with β values of CDSM obtained from the multi-level models to further evaluate the clinical significance.Results: Scores for CHF-PROM improved significantly after discharge. The multilevel models showed that a regular schedule, avoidance of over-eating, a low-sodium diet and exercise increased scores on CHF-PROM. Compared with the MCID, avoidance of over-eating almost every day (13.60 vs. 10.71) and maintenance of a regular schedule often (12.03 vs. 10.71) reached clinical significance for the overall summary. Avoidance of over-eating (4.56 vs. 4.14) and a regular schedule almost every day (4.76 vs. 4.14) reached clinical significance for the physical scores. Avoidance of over-eating often (5.73 vs. 5.35) and a regular schedule almost every day (6.36 vs. 5.35) demonstrated clinical significance for the psychological scores.Conclusions: This study observed an association of avoidance of over-eating and maintenance of a regular schedule with the improvement of CHF-PROM. It provides further evidence for management of heart failure.Trial registration: 2018LL128, RegisteredJanuary 2, 2018-Prospective registered, http://www.sxmu.edu.cn/.

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Section: Mcid and Its Interpretation To The Multilevel Modelsupporting

confidence: 62%

Assessment of Chronic Disease Self-management in Patients With Chronic Heart Failure Based on the MCID of Patient-reported Outcomes by the Multilevel Model

Tian

Zhao

Zhang

et al. 2020

Preprint

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“…In the present study, we confirmed that an LSD increased OS, PHYS, and PSYS of CHF-PRO. Previous studies and the ongoing Geriatric Out-of-Hospital Randomized Meal Trial in Heart Failure (GOURMET-HF) study applied the KCCQ summary score as an indicator of QoL outcome and drew the same conclusion as that in our study [23][24][25]. Regarding PHYS, the reason for the increase may be that an LSD improved symptoms and signs of CHF [26,27] and promoted exercise tolerance in patients [27].…”

Section: Mcid and Its Interpretation To The Multilevel Modelsupporting

confidence: 62%

Influence of self-management on patient-reported outcomes for individuals with chronic heart failure: a multilevel model approach from a longitudinal study

Zhao

Zhang

Ren

et al. 2020

Preprint

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KEYWORDSpatient reported outcome, chronic heart failure, self-management, multilevel model, minimal clinically important difference 2 Abstract Purpose: Self-management is highly heterogenous in patient-reported outcomes in individuals with chronic heart failure and lacks a clinical definition. The aim of this study was to identify clinically meaningful strategies that improve patient-reported outcomes in those with chronic heart failure.Methods: A total of 555 patients with heart failure were enrolled. Self-management advice was provided in written form at discharge. Information regarding chronic heart failure in patient-reported outcomes and self-management was collected during follow-up. Multilevel models were applied to evaluate the effects of self-management strategies for patient-reported outcome of chronic heart failure (CHF-PRO) scores, as well as its physical and psychological domains. Minimal clinically important difference was introduced to further evaluate clinical significance.Results: Scores for CHF-PRO improved significantly after discharge. A regular schedule, avoidance of over-eating, and a low-sodium diet increased scores on patient-reported outcomes, including overall scores and physical and psychological scores. In addition, exercise improved patient-reported outcomes and its physical domain. The use of angiotensin-converting enzyme inhibitors also increased physical scores. Among these variables, a regular daily schedule and avoidance of overeating almost every day reached clinical significance for CHF-PRO scores, as well as its physical and psychological domains.Conclusions: Self-management, especially the avoidance of over-eating and maintenance of a regular schedule, should be implemented to improve patient-reported outcomes in those with chronic heart failure.

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“…Hence, in achieving euvolemia, there may be more benefit in maintaining a consistent day‐to‐day level of sodium intake vs lowering dietary sodium to levels where patients may not be able to consistently adhere. As noted by Doukky and colleagues, high‐quality RCTs are needed to elucidate the impact of dietary sodium on clinical outcomes in HF, for which two known trials are currently recruiting (the Study of Dietary Intervention Under 100 mmol in Heart Failure [SODIUM‐HF] and the Geriatric Out of Hospital Randomized Meal Trial in Heart Failure [GOURMET‐HF]) …”

Section: Discussionmentioning

confidence: 99%

The science of salt: A regularly updated systematic review of salt and health outcomes (December 2015–March 2016)

Wong

Arcand

Leung

et al. 2017

J of Clinical Hypertension

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The purpose of this review was to identify, summarize, and critically appraise studies on dietary salt relating to health outcomes that were published from December 2015 to March 2016. The search strategy was adapted from a previous systematic review on dietary salt and health. Overall, 13 studies were included in the review: one study assessed cardiovascular events, nine studies assessed prevalence or incidence of blood pressure or hypertension, one study assessed kidney disease, and two studies assessed other health outcomes (obesity and nonalcoholic fatty liver disease). Four studies were selected for detailed appraisal and commentary. One study met the minimum methodologic criteria and found an increased risk associated with lower sodium intake in patients with heart failure. All other studies identified in this review demonstrated positive associations between dietary salt and adverse health outcomes. | INTRODUCTIONExcess salt (sodium) consumption is associated with many adverse health effects, including hypertension and cardiovascular mortality.1,2 Based on the evidence from systematic reviews assessing dietary sodium reduction, the World Health Organization (WHO) recommends a sodium intake of <2 g/d (equivalent to 5 g/d of salt) in adults, with lower amounts for children based on their energy requirements relative to those of adults. 3,4 All WHO Member States have agreed on a target of reducing dietary sodium intake by 30%by 2025. 5Regularly updated reviews and critical appraisals of identified studies relating to health outcomes are published in the Journal of Clinical Hypertension, alternating with reviews of studies relating to salt reduction implementation programs. The last review of salt and health outcomes covered studies published between August and November 2015. | METHODOLOGYA detailed description of the methodological approach used to identify and evaluate the literature in this review has been previously published. 7 In summary, articles were identified on a weekly basis through a MEDLINE search strategy. 7 Studies examining the effects of salt on health outcomes, including studies of participants with any comorbidity (with the exception of acute illness), that were published from December 1, 2015 to March 31, 2016, were included in this review.All included studies were assessed for risk of bias by two independent reviewers. Randomized controlled trials (RCTs) were assessed using the Cochrane risk of bias tool. 8 Observational, nonrandomized studies were assessed using a modified Cochrane risk of bias tool. 9 For systematic reviews and meta-analyses, the c tool was applied. 10We identified the subset of included studies that met previously established minimum methodologic criteria for clinical and population studies on dietary salt 11 (Box). Detailed appraisals and written commentary were performed for these studies. Other studies were then selected for detailed review based on two independent reviewers identifying them either as potentially high impact, controversial, or important in terms ...

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The long-term effects of dietary sodium restriction on clinical outcomes in patients with heart failure. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure): A pilot study

Cited by 58 publications

References 35 publications

Assessment of Chronic Disease Self-management in Patients With Chronic Heart Failure Based on the MCID of Patient-reported Outcomes by the Multilevel Model

Assessment of Chronic Disease Self-management in Patients With Chronic Heart Failure Based on the MCID of Patient-reported Outcomes by the Multilevel Model

Influence of self-management on patient-reported outcomes for individuals with chronic heart failure: a multilevel model approach from a longitudinal study

The science of salt: A regularly updated systematic review of salt and health outcomes (December 2015–March 2016)

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