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Take a look at a selection of our recent media coverage:

Reduced sodium intake does not lower clinical events in heart failure patients

12th April 2022

A reduced sodium intake has no impact on clinical events in heart failure patients but does slightly improves QOL and disease functional class

A randomised trial by researchers from the Canadian VIGOUR Centre, University of Alberta, Canada showed that reduced sodium intake had no effect on clinical events including cardiovascular-related hospitalisations or mortality in ambulatory heart failure patients compared with usual care, but did have a small, but significant, positive effect on quality of life and improved disease functional class.

In patients with congestive heart failure, the reduced low cardiac output decreases the fullness of the arterial circulation initiates several internal mechanisms to increase vascular resistance and enhance sodium and water renal retention. In fact, in a study that examined factors associated with a worsening of heart failure, noncompliance with salt restriction, was a factor in over a fifth (22%) of cases.

As a result, dietary advice advocating a reduced sodium intake is arguably the most frequent self-care behaviour recommendation to patients with heart failure and is endorsed by all heart failure guidelines. Currently, the American Heart Association recommends a reduction of sodium intake to <2300 mg/d for general cardiovascular health promotion but notes how there are no trials to support this level of restriction in patients with heart failure.

Nevertheless, the beneficial effect of lowering sodium intake is not clear cut and some evidence suggests that a reduced sodium intake to less than 2g/day is unwarranted in mild heart failure. In contrast, other data shows that sodium restriction (< 2.5 g/day) was associated with a significantly higher risk of death or heart failure hospitalisation

With some uncertainties over whether a reduced sodium intake was beneficial to those with heart failure, for the present study, the Canadian team examined the effect of a dietary intervention of less than 1.5 g/day (1500 mg) of sodium compared to usual care, i.e., where no such recommendation was in place. Included patients had chronic heart failure (New York Heart Association functional class, 2 – 3) and had optimal medical therapy. Individuals were then randomised 1:1 to the low sodium diet or usual care. The low sodium intervention was supported by behavioural counselling and meal plans and menus for a period of 12 months. Dietary sodium intake was assessed using a 3-day food record at baseline and again after 6 and 12 months for both groups. The primary outcome of interest was a composite of cardiovascular-related hospitalisation, cardiovascular-related emergency department visits and all-cause mortality within 12 months of randomisation. In addition, to the clinical outcomes, quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, as well any changes in the New York Heart Association functional class.

Reduced sodium intake and cardiovascular outcomes

A total of 806 patients with median age of 67 years (66% male) were randomised to the low sodium arm (397) or usual care. At baseline the median sodium intake was 2286 mg/day for the low sodium group and 2119 mg/day for control arm. After 12 months, the sodium intake reduced by 4% in the control arm but by 28% in the low sodium group.

Within 12 months, the primary outcome occurred in 15% of those in the low sodium arm and 17% in the usual care group (adjusted hazard ratio, HR = 0.99, 95% CI 0.66 – 1.47, p = 0.95). All-cause mortality rates were also similar (6% vs 4%, low sodium vs usual care), giving a hazard ratio of 1.35 (95% CI 0.64 – 2.82, p = 0.43).

Whilst there were no significant differences in clinical outcomes, participants assigned to the low sodium group did see a small, but significant increase in the overall KCCQ summary score of 3.38 points (p = 0.011) and those in the low sodium group had a greater odds of improving by one NYHA functional class compared to the usual care group (odds ratio, OR = 0.59, 95% CI 0.40 – 0.86, p = 0.006).

The authors concluded that while a low sodium diet did not impact significantly on clinical outcomes, it did produce small but significant improvements in quality of life and NYHA functional class.

Citation
Ezekowitz JA et al. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial Lancet 2022

Heart failure patients at increased risk of cancer and cancer-related mortality

28th January 2022

Heart failure (HF) patients have a higher risk of cancer and cancer-related mortality compared to matched-controls according to research by a team from the Cardiovascular Disease Unit, Genoa, Italy.

There is emerging evidence that the incidence of cancer is higher among those with cardiovascular disease and heart failure and this latter group frequently die from cancer. In fact, research has uncovered the increased risk of cancer among HF patients, persists beyond the first year after their HF diagnosis and that their prognosis is worse compared to non-heart failure patients with cancer. Despite this purported association, other work among 28,341 Physicians’ Health Study participants, has shown that HF is not associated with an increased risk of cancer among male physicians. It has also been suggested that while heart failure patients did have a slightly increased risk of various cancer subtypes, these increased risks were largely drive by comorbidities.

Given this potential uncertainty over the HF-cancer association, the Italian team attempted to provide greater clarity by undertaking a retrospective cohort study of healthcare records in Puglia, a region of southern Italy. They included patients aged 50 years and older, diagnosed with heart failure but without a history of cancer in the three years prior to their inclusion in the analysis. The team included a control group without HF who were matched on age and sex. The primary outcomes of the study were cancer incidence as well as mortality. In an effort to examine whether HF severity influenced the study outcomes, the researchers also explored patients use of doses in excess of 80 mg/day of furosemide and equivalents for longer than 30 days in the year before the index date.

Heart failure patients and cancer

A total of 104,020 HF patients with a mean age of 76 years were matched to an equal number of control patients. The researchers identified a total of 12,036 new diagnoses of cancer in HF patients and 7,045 in controls after a median follow-up period of 5 years. This gave an incidence cancer rate of 21.36 per 1000 person-years among those with HF and 12.42 in the control arm (Hazard ratio, HR = 1.76, 95% CI 1.71 – 1.81).

The cancer mortality rate was also higher among HF patients compared with controls (HR = 4.11, 95% CI 3.86 – 4.38). This difference was also seen among HF patients aged less than 70 years (HR = 1.66, 95% CI 1.58 – 1.75) and in those over 80 years of age (HR = 2.07).

High dose loop diuretics also showed an important effect with a higher cancer incidence (HR = 1.11, 95% CI 1.03 – 1.21) and cancer-related mortality (HR = 1.35).

The authors concluded that HF patients had both a higher incidence of cancer and cancer mortality than matched controls and speculated that given that the risk was elevated among those with high dose loop diuretics, it was possible that the overall cancer risks were potentially higher in those with decompensated, i.e., more severe HF.

Citation

Bertero E et al. Cancer Incidence and Mortality According to Pre-Existing Heart Failure in a Community-Based Cohort JACC CardioOncology 2022

Sodium-glucose cotransporter 2 inhibitors associated with cardiovascular benefits

26th January 2022

Sodium-glucose cotransporter 2 inhibitors (SGLT2-Is) reduce adverse cardiovascular outcomes according to a meta-analysis of clinical trials

SGLT2-Is can be considered as an effective class of drugs to improve cardiovascular morbidity and mortality. This was the conclusion of a meta-analysis by researchers from the Division of Cardiology, Southern Illinois University School of Medicine, US.

SGLT2-Is were developed and licensed as a class of drugs for the management of type 2 diabetes and one agent in particular, dapagliflozin, has been shown, as an add-on drug to conventional anti-diabetic drugs, to improve glycaemic control. However, with more widespread use of these drugs, it became apparent that there were potential cardioprotective effects, such as a reduction in the worsening of heart failure, irrespective of whether or not the patients were diabetic.

For the present study, the US researchers, set out to establish whether the magnitude of any cardiovascular benefit from SGLT2-Is were generalisable to patients of different ages and ethnicities. They searched for placebo-controlled randomised clinical trials in patients with existing atherosclerotic cardiovascular disease (ASCVD) or the presence of risk factors for ASCVD such as diabetes or heart failure. They set the primary outcome as cardiovascular death or hospitalisation for heart failure (HHF) and major cardiovascular events (MACE), HHF, cardiovascular death, acute myocardial infarction and all-cause mortality as secondary outcomes. They included gender, age (< 65 or > 65) and ethnicity as subgroups for separate analyses.

Findings

A total of 10 trials including 71,553 patients were analysed with 39,053 who received SGLT2-Is.

The primary outcome of cardiovascular death or HHF was reported in all trials and there were 6921 incidents, 8.1% occurring in those given SGLT2-Is and 11.6% in the placebo group. The use of SGLT2-Is was calculated to be associated with 33% reduced risk of the primary outcome (odds ratio, OR = 0.67, 95% CI 0.55 – 0.80, p < 0.01).

There was also a reduced risk of MACE in those taking SGLT2-Is (OR = 0.90, 95% CI 0.81 – 0.99, p = 0.03). However, there was no difference in the rate of acute myocardial infarction in those taking SGLT2-Is compared to placebo (OR = 0.95, 95% CI 0.87 – 1.03). Moreover, subgroup analysis favoured the use of SGLT2-Is in all groups compared and all-cause mortality was also lower in those taking SGLT2-Is (OR = 0.87, 95% CI 0.80 – 0.96, p = 0.04).

The authors concluded that the ‘cardiovascular outcomes of SGLT2-I therapy can be compared across all trials, and it demonstrates remarkable consistency of class benefit, despite the variations in populations enrolled.’

Citation

Bhattarai M et al. Association of Sodium-Glucose Cotransporter 2 Inhibitors With Cardiovascular Outcomes in Patients With Type 2 Diabetes and Other Risk Factors for Cardiovascular Disease: A Meta-analysis. JAMA 2022

Sex-related heart failure mortality influenced by left ventricular ejection fraction

4th January 2022

Sex-related differences in mortality in patients with heart failure hospitalisations appear to be affected by the left ventricular ejection fraction according to researchers from the Cardiology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.

Although the risk of heart failure (HF) is similar between men and women, there are some notable sex-related differences, with men being predisposed to HF with reduced ejection fraction and women with preserved ejection fraction. Although there is some evidence that women with HF live longer than men, they experience more psychological and physical disability. However, much of the available data is derived from patients with stable HF and what is less clear, is if there are any sex-related prognostic differences among patients hospitalised following decompensated heart failure.

For the present study, the Spanish team retrospectively examined gender differences in mortality across the left ventricular ejection fraction spectrum in a cohort of patients after a hospitalisation for acute HF. The researchers used a multi-centre prospective registry of those hospitalised and collected demographics, medical history, laboratory and echocardiographic parameters and followed patients over a 6-month period. The primary study endpoints were all-cause, cardiovascular and HF-related mortality. Cardiovascular death was considered secondary to a worsening of HF, acute myocardial infarction, stroke or transient ischaemic attack, whereas HF-related deaths were considered secondary to a worsening of the HF or a sudden cardiac death.

Findings

A total of 4812 patients with a mean age of 74.2 years (46.6% women) were included in the analysis. The proportion of patients with a left ventricular ejection fraction (LVEF) of < 40%, 41 – 49% and > 50% was 31.5%, 14.3% and 54.2% respectively. Women were generally older with a mean age of 76.8 years compared to 71.9 years for men and had a higher preserved ejection fraction (70.5% vs 39.9%, female vs male, p < 0.001).

After 6 months, 645 (13.4%) of the patients had died with mortality rates of 13.3% and 13.5% (women vs men, p = 0.82) and there were no significant sex-related differences in all-cause mortality. Moreover, LVEF was not an independent predictor of mortality (HR = 1.02, 95% CI 0.99 – 1.05, p = 0.13). Similarly, rates of cardiovascular mortality were not different between the sexes. However, there was a significant interaction between sex and levels of LVEF (p for interaction = 0.030) and women had a significantly lower risk of cardiovascular mortality at lower LVEF levels (< 25%). There were also no differences between the sexes in HF-related mortality although as with cardiovascular mortality, there were differences across the levels of LVEF and women had a reduced risk of HR-related death. For example, compared to men, women had a reduced risk of HF death at a LVEF of < 43% (HR = 0.77, 95% CI 0.59 – 0.99) In contrast, this risk of death in women became higher as the LVEF increased above 80%.

Commenting on these findings, the authors noted that while sex was not a determinant of 6 month all-cause mortality, women had a lower risk of cardiovascular and HR-related mortality where the LVEF was < 25% and < 43% but higher where the LVEF was > 80%. They concluded that further work is required to confirm these findings and to evaluate the potential negative implications of a supra-normal LVEF in women with a preserved ejection fraction.

Citation

Santas E et al. Sex-Related Differences in Mortality Following Admission for Acute Heart Failure Across the Left Ventricular Ejection Fraction Spectrum J Am Heart Assoc 2021

Aspirin use linked to increased risk of heart failure

29th November 2021

Aspirin use among patients both with and without cardiovascular disease is associated with an increased risk of incident heart failure

Aspirin use is associated with an more than a 20% increased risk of heart failure in those with and without cardiovascular disease according to the results of an analysis by researchers from the Research Unit Hypertension and Cardiovascular Epidemiology, University of Leuven, Belgium.

Heart failure (HF) is best described as a clinical syndrome and which is characterised by symptoms including breathlessness, ankle swelling and fatigue, due to structural and/or functional cardiac abnormality, leading to a reduced cardiac output and/or intra-cardiac pressures at rest or during stress. Furthermore, HF is associated with a associated with a hyper coagulable state and autopsy studies have found that acute coronary events are frequent in HF patients who die suddenly, highlighting the potential value of using anti-thrombotic therapy. Although low dose aspirin is no longer recommended for the primary prevention of cardiovascular disease, the role of anti-thrombotic therapy in heart failure is less clear with one study concluding that there was ‘no evidence that aspirin is effective or safe in patients with heart failure.’ In contrast, a 2014 study concluded that ‘low-dose aspirin therapy was associated with a significant reduction in mortality and morbidity risk’ in patients with heart failure.

With some uncertainty over the value of aspirin use in patients with HF, the Belgian researchers sought to gain a better understanding of the role and value of aspirin. They turned to the Heart ‘Omics’ in aGEing (HOMAGE) database, which contains patient-level data for over 30,000 individuals from 21 studies and developed models to examine the impact of aspirin using both a derivation and validation set. At baseline all participants were free of heart failure and at the time of entry into studies, aspirin use was recorded and patients dichotomised as either ‘users’ or ‘non-users’. Other data included in the subsequent analysis were demographics and relevant clinical information such as the presence of co-morbidities and any history of cardiovascular disease.

Findings

In the HOMAGE dataset, the study population included 30,827 individuals (19,257 in the derivation set) with a mean age of 66.8 years (33.9% women). Overall, 26.4% had a a history of coronary artery disease and the biggest co-morbidity was hypertension (85.8%).

After a median follow-up period of 5.3 years, 1330 patients experienced either fatal or non-fatal HF with an incident rate of 14.5% (95% CI 13.4 – 15.7%) in the aspirin use group versus 5.9% (95% CI 5.5 – 6.4%) in the ‘non-aspirin’ group. In the HOMAGE dataset, the fully adjusted hazard ratio for aspirin use in those with cardiovascular disease was 1.26 (95% CI 1.12 – 1.41, p < 0.001) and 1.23 (95% CI 1.06 – 1.41, p = 0.004) among those without cardiovascular disease.

Commenting on these findings, the authors concluded that aspirin use increased the risk of incident HF in patients with and without prior cardiovascular disease, adding that ‘our observations suggest that aspirin should be prescribed with caution in patients at risk of HF or having HF.’

Citation

Mujaj B et al. Aspirin use is associated with increased risk for incident heart failure: a patient‐level pooled analysis. ESC Heart Fail 2021

No effect of systolic BP on cardiovascular outcomes in heart failure treated with empagliflozin

4th October 2021

Systolic BP has been shown not to effect the reduction in cardiovascular outcomes for heart failure patients treated with empagliflozin.

As a drug class, the sodium-glucose cotransporter-2 inhibitors (SGLT2is) have been shown in a systematic review to have a moderate effect on major adverse cardiovascular events in patients with established atherosclerotic cardiovascular disease. Moreover, the same review identified how SGLT2is can also reduce hospitalisation for heart failure (HF) and progression of renal disease regardless of existing atherosclerotic cardiovascular disease. In addition to these positive effects on cardiovascular outcomes, SGLT2is have been shown to reduce 24-hour blood pressure (BP) in diabetic patients. Nevertheless, this blood pressure-lowering effect is of concern in those with HF, especially as between 15 and 20% of HF patients have low systolic BP and therefore at a higher risk of in-hospital and post-discharge mortality.

In an effort to evaluate whether the baseline systolic BP affected outcomes associated with the use of empagliflozin, an international team, led by researchers from Saarland University, Germany, enrolled patients in the Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction (EMPEROR-Reduced) trial. Patients with class II, III, or IV heart failure and an ejection fraction of less than 40% were randomised in a 1:1 fashion to either empagliflozin (10mg daily) or placebo in addition to their usual therapy for heart failure. For the study, patients were grouped according to their baseline systolic BP, as <110mmHg, 110–130mmHg or > 130mmHg and the primary outcome in the EMPEROR-Reduced trial was a composite of adjudicated cardiovascular death or hospitalisation for heart failure. For the present study, the researchers focused on whether the baseline systolic BP influenced the outcomes of cardiovascular death and hospitalisations for HF in patients given empagliflozin compared to placebo.

Findings

A total of 3730 patients were randomised to either empagliflozin (1863) or placebo and all patients had a left ventricular ejection fraction of less than 30%. Over a median of 16 months, the event rate per 100 patients years (pys) of follow-up, the primary outcome increased from 16.5 among the high SBP group to 20.8 for the intermediate group, and to 26.3 per 100 among the patients with low SBP (p=0.0015). Compared with placebo, treatment with empagliflozin significantly decreased the risk of cardiovascular death among the low systolic BP (hazard ratio, HR = 0.78, 95% CI 0.61–1.00), intermediate (HR = 0.71, 95% CI 0.58–0.87) and high (HR = 0.82. 95% CI 0.62–1.09) groups. However, while there were reductions in rates of HF hospitalisation with empagliflozin compared with placebo, this was only significant for patients with intermediate (110–130mmHg) systolic BP (HR = 0.66, 95% CI 0.50–0.88).

The authors concluded that empagliflozin reduced the risk of cardiovascular death and the number of HF hospitalisations and that this effect occurred independently of the baseline systolic BP.

Citation

Bohm M et al. Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure. J Am Coll Cardiol 2021.

Increased cancer risk among those with heart failure

6th July 2021

A retrospective cohort study of heart failure patients has revealed a significantly higher incidence of all types of cancer.

Patients with heart failure (HF) have both a functional impairment and a poor health-related quality of life. However, it is not always the HF which has the biggest impact on quality of life. For example, one study of over 700 HF patients, found that less than half (48%) reported that their quality of life was limited by heart failure, with nearly a fifth (18%) citing other medical problems as the dominant factor. Similarly, a Swedish study of 10,500 patients observed that depression and anxiety had the strongest associations with functional limitations and patient-rated health. In fact, Heart failure has a poor prognosis and a UK study estimated 10-years survival to be only 26.2%.

Interestingly, other data point to a potential relationship between the presence of heart failure and cancer. In 2020 it was observed that among patients with ejection fractions less than 45%, cancer accounted for 6 to 14% of all deaths and was independent of treatment. This led the authors to conclude that cancer is a major, yet overlooked cause of non-cardiovascular death in heart failure. Given this potentially overlooked cause of death, a team from the Clinic for Gastroenterology, Hepatology and Infectious Diseases, University Hospital, Dusseldorf, Germany, undertook a retrospective analysis of the incidence of cancer in patients after a diagnosis of HF. The team turned to the German Disease Analyser database, which contains information on prescriptions, diagnoses together with basic demographic and medical data in an anonymous format that comes directly from a sample of general practitioners and specialists throughout the country. For their analysis, included patients were over 18 years of age with an initial diagnosis of HF and individuals already diagnosed with cancer were excluded from the dataset. Patients with HF were propensity-matched by sex, age, yearly consultation frequency together with the presence of two co-morbidities; obesity and diabetes and followed for a period of 10 years.

Findings
A total of 100,124 patients with a mean age of 72.6 years (54% female) were matched with a non-heart failure cohort. Diabetes and obesity were present in 37.4% and 15.9% respectively in the heart failure group and patients visited their general practitioner an average of six times per year. The prevalence of cancer in HF patients was 25.7% compared with 16.2% in the control cohort (p < 0.001). This pattern was similar for both sexes, with 23.2% vs 13.8% (males) and 28.6% vs 18.8% (females). In regression analysis, heart failure was significantly associated with the incidence of cancer (hazard ratio (HR) = 1.76, 95% CI 1.71–1.81, p < 0.001), with a similar and significant effect seen in the two sexes, i.e., males (HR = 1.69) and females (HR = 1.69). When examining the relationship between cancer location and HF, the strongest association was for the lip, oral cavity and pharynx (HR = 2.10, 95% CI 1.66–2.17, p < 0.001), followed by respiratory organs (HR = 1.91) and female genital cancer (HR = 1.86).

While the authors suggested that these associations were not indicative or a direct causal relationship, they noted evidence from other work indicating how circulating levels of cardiovascular peptides such as N-terminal pro BNP are elevated in heart failure patients with cancer. They concluded by calling for future studies to clarify this relationship.

Citation
Roderburg C et al. Heart failure is associated with an increased incidence of cancer diagnosis. ESC Heart Fail 2021