Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial.

BACKGROUND: Dietary restriction of sodium has been suggested to prevent fluid overload and adverse outcomes for patients with heart failure. We designed the Study of Dietary Intervention under 100 mmol in Heart Failure (SODIUM-HF) to test whether or not a reduction in dietary sodium reduces the incidence of future clinical events. METHODS: SODIUM-HF is an international, open-label, randomised, controlled trial that enrolled patients at 26 sites in six countries (Australia, Canada, Chile, Colombia, Mexico, and New Zealand). Eligible patients were aged 18 years or older, with chronic heart failure (New York Heart Association [NYHA] functional class 2-3), and receiving optimally tolerated guideline-directed medical treatment. Patients were randomly assigned (1:1), using a standard number generator and varying block sizes of two, four, or six, stratified by site, to either usual care according to local guidelines or a low sodium diet of less than 100 mmol (ie, <1500 mg/day). The primary outcome was the composite of cardiovascular-related admission to hospital, cardiovascular-related emergency department visit, or all-cause death within 12 months in the intention-to-treat (ITT) population (ie, all randomly assigned patients). Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT02012179, and is closed to accrual. FINDINGS: Between March 24, 2014, and Dec 9, 2020, 806 patients were randomly assigned to a low sodium diet (n=397) or usual care (n=409). Median age was 67 years (IQR 58-74) and 268 (33%) were women and 538 (66%) were men. Between baseline and 12 months, the median sodium intake decreased from 2286 mg/day (IQR 1653-3005) to 1658 mg/day (1301-2189) in the low sodium group and from 2119 mg/day (1673-2804) to 2073 mg/day (1541-2900) in the usual care group. By 12 months, events comprising the primary outcome had occurred in 60 (15%) of 397 patients in the low sodium diet group and 70 (17%) of 409 in the usual care group (hazard ratio [HR] 0·89 [95% CI 0·63-1·26]; p=0·53). All-cause death occurred in 22 (6%) patients in the low sodium diet group and 17 (4%) in the usual care group (HR 1·38 [0·73-2·60]; p=0·32), cardiovascular-related hospitalisation occurred in 40 (10%) patients in the low sodium diet group and 51 (12%) patients in the usual care group (HR 0·82 [0·54-1·24]; p=0·36), and cardiovascular-related emergency department visits occurred in 17 (4%) patients in the low sodium diet group and 15 (4%) patients in the usual care group (HR 1·21 [0·60-2·41]; p=0·60). No safety events related to the study treatment were reported in either group. INTERPRETATION: In ambulatory patients with heart failure, a dietary intervention to reduce sodium intake did not reduce clinical events. FUNDING: Canadian Institutes of Health Research and the University Hospital Foundation, Edmonton, Alberta, Canada, and Health Research Council of New Zealand.

Chronic disease health literacy in First Nations people: A mixed methods study.

AIM: To explore chronic disease education, self-management and health literacy abilities from First Nations Australian adults with chronic disease through the integration of qualitative and quantitative findings. BACKGROUND: Chronic disease management requires good health literacy abilities to manage long-term health needs. First Nations people have a higher burden of chronic disease although little is known regarding chronic disease health literacy of First Nations people. DESIGN: A concurrent embedded mixed methods study reported using the Consolidated Criteria for Reporting Qualitative Research guidelines. METHODS: Data were collected from First Nations people with one or more chronic diseases living in remote Australia between February-November 2017. Quantitative data (n = 200) were collected using the Health Literacy Questionnaire along with demographic and health data. Qualitative data (n = 20) were collected via face-to-face interviews to examine chronic disease education and self-management experiences. Data were analysed separately then integrated to develop meta-inferences. RESULTS: Poor communication from healthcare providers coupled with low health literacy abilities is a major barrier to both active and successful management of chronic disease. Communicating in medical jargon resulted in individuals being placed in a power differential causing lack of trust and relationship breakdowns with healthcare providers affecting active chronic disease self-management. The perception of inevitability and ambivalence towards chronic disease and the notion of futility towards self-management were concurred with the low level of active engagement in health care. CONCLUSIONS: Yarning is an important strategy used by First Nations people for communication. For nurses, understanding and developing skills in yarning will facilitate cultural safety, communication and understanding about chronic disease self-management in contexts where health literacy abilities are challenged. RELEVANCE TO CLINICAL PRACTICE: Using yarning, and plain language visual aids, and teach-back will readdress the power differential experienced by First Nations people and may also improve understanding of chronic disease self-management.

Impact of Patient and Model of Care Factors on Titration and Tolerability of Sacubitril/Valsartan: An Early Australian Real-World Experience.

BACKGROUND: Sacubitril/valsartan was shown to be superior to enalapril in the Prospective Comparison of angiotensin receptor neprilysin inhibitor with an angiotensin converting enzyme inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) study. However, the study design raised uncertainty about the potential real-world tolerability amongst less well selected cohorts. We aimed to examine the real-world tolerability and factors associated with successful titration of sacubitril/valsartan. METHODS: We performed a retrospective single centre analysis in a tertiary referral centre of 235 consecutive patients prescribed sacubitril/valsartan between August 2016 and January 2018. RESULTS: At baseline, our patients were younger, had lower baseline systolic blood pressure (SBP), reduced ischaemic aetiology and a higher rate of mineralocorticoids receptor antagonist compared to PARADIGM-HF. At last assessment, 120 patients (51%) reached target dose (97/103 mg bi-daily [BD]), 67 patients (29%) were stable on a mid-range dose (≥49/51 mg BD), 22 patients (9%) tolerated the low dose (24/26 mg BD) and 26 patients (11%) discontinued, comparable to PARADIGM-HF. Adverse effects were similar to PARADIGM-HF and hypotension remained the primary reason of sub-maximal titration. Several baseline characteristics were associated with successful titration to target dose including; higher baseline body mass index, systolic blood pressure (SBP) and sodium, male gender and treatment coordinated by multidisciplinary heart failure (HF) clinic. CONCLUSION: Comparable results to PARADIGM-HF in attaining target dose of sacubitril/valsartan and tolerability profile can be achieved in a real-world setting. Several baseline characteristics involving patient factors, markers of disease severity and systems of care predict successful titration to the target dose 97/103 mg BD.

Correction to: Health literacy in indigenous people with chronic disease living in remote Australia.

In the original publication of this article [1], some values are missing in Table 3. Table 3 is revised in the updated figure below.

Health literacy in Indigenous people with chronic disease living in remote Australia.

BACKGROUND: Health literacy is strongly associated with health outcomes and is important for health policy and service delivery. Low health literacy was reported in 59% of Australian adults, however, there is no national data on the health literacy of Aboriginal and Torres Strait Islander (ATSI) peoples. The ATSI population in Australia experience a notable gap in health outcomes compared with non-Indigenous Australians which is due, in part to a higher prevalence of chronic diseases. The health outcome gap is more pronounced in rural and remote locations. This study aims to establish the health literacy profile of ATSI adults with chronic disease living in remote North-West Queensland Australia, and to investigate associations between the Health Literacy Questionnaire (HLQ) domains and self-reported chronic disease and demographic characteristics. METHODS: Using a cross-sectional design, 200 ATSI adults with a diagnosis of chronic disease/s (cardiovascular disease, diabetes, respiratory disease and/or chronic kidney disease) were recruited from two sites with the assistance of Aboriginal Health Workers. Data were collected using the HLQ, a multidimensional 44 item instrument to assess nine domains of health literacy. Demographic and health data were also collected. Analysis of variance using backwards modelling was used to determine predictors of health literacy. RESULTS: Participants were mostly male (53.5%) and aged between 19 and 89 years. The most prevalent chronic disease was cardiovascular disease (74%) followed by diabetes (67.5%). More than half (62%) had two or more chronic diseases. There was at least one independent predicator for each of the nine health literacy domains. Age, number of chronic diseases, gender, and level of education were all highly significant predictors of health literacy. CONCLUSION: Improved health literacy will enable individuals to take an active role in their health. Understanding the health literacy of ATSI adults is a crucial first step. Our findings can assist Australian healthcare organisations to review their health literacy responsiveness and examine ways to improve patients' needs and health capabilities to better support people to engage in effective self-management for chronic diseases.

Who 'nose', is it the angiotensin receptor neprilysin inhibitor?: a case series of persistent nasal pruritus in heart failure patients receiving sacubitril/valsartan.

BACKGROUND: Sacubitril/valsartan is approved for the treatment of chronic heart failure with reduced left ventricular ejection fraction of ≤40% to decrease mortality and morbidity. Nasal pruritus is not a recognized adverse effect in the product information. In this case series, we encountered three patients who presented with nasal pruritus that improved after discontinuation of sacubitril/valsartan. CASE SUMMARY: Three patients aged 58-73 years-old presented with pruritus at the nasal septum post-initiation of sacubitril/valsartan. The pruritus did not subside despite the use of anti-histamines. Within 3-6 months, all individuals discontinued sacubitril/valsartan with complete resolution of their nasal pruritus. DISCUSSION: Many physicians may not aware of this unusual but reversible adverse effect of sacubitril/valsartan. Despite the positive prognostic value of sacubitril/valsartan, the constant nasal pruritus had impacted the quality of life of our patients, leading them to discontinue sacubitril/valsartan permanently.