Lifestyle Walking Intervention for Patients With Heart Failure With Reduced Ejection Fraction: The WATCHFUL Trial.

BACKGROUND: Physical activity is pivotal in managing heart failure with reduced ejection fraction, and walking integrated into daily life is an especially suitable form of physical activity. This study aimed to determine whether a 6-month lifestyle walking intervention combining self-monitoring and regular telephone counseling improves functional capacity assessed by the 6-minute walk test (6MWT) in patients with stable heart failure with reduced ejection fraction compared with usual care. METHODS: The WATCHFUL trial (Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction) was a 6-month multicenter, parallel-group randomized controlled trial recruiting patients with heart failure with reduced ejection fraction from 6 cardiovascular centers in the Czech Republic. Eligible participants were ≥18 years of age, had left ventricular ejection fraction <40%, and had New York Heart Association class II or III symptoms on guidelines-recommended medication. Individuals exceeding 450 meters on the baseline 6MWT were excluded. Patients in the intervention group were equipped with a Garmin vívofit activity tracker and received monthly telephone counseling from research nurses who encouraged them to use behavior change techniques such as self-monitoring, goal-setting, and action planning to increase their daily step count. The patients in the control group continued usual care. The primary outcome was the between-group difference in the distance walked during the 6MWT at 6 months. Secondary outcomes included daily step count and minutes of moderate to vigorous physical activity as measured by the hip-worn Actigraph wGT3X-BT accelerometer, NT-proBNP (N-terminal pro-B-type natriuretic peptide) and high-sensitivity C-reactive protein biomarkers, ejection fraction, anthropometric measures, depression score, self-efficacy, quality of life, and survival risk score. The primary analysis was conducted by intention to treat. RESULTS: Of 218 screened patients, 202 were randomized (mean age, 65 years; 22.8% female; 90.6% New York Heart Association class II; median left ventricular ejection fraction, 32.5%; median 6MWT, 385 meters; average 5071 steps/day; average 10.9 minutes of moderate to vigorous physical activity per day). At 6 months, no between-group differences were detected in the 6MWT (mean 7.4 meters [95% CI, -8.0 to 22.7]; P=0.345, n=186). The intervention group increased their average daily step count by 1420 (95% CI, 749 to 2091) and daily minutes of moderate to vigorous physical activity by 8.2 (95% CI, 3.0 to 13.3) over the control group. No between-group differences were detected for any other secondary outcomes. CONCLUSIONS: Whereas the lifestyle intervention in patients with heart failure with reduced ejection fraction improved daily steps by about 25%, it failed to demonstrate a corresponding improvement in functional capacity. Further research is needed to understand the lack of association between increased physical activity and functional outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03041610.

Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial.

BACKGROUND: Physical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients' compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients. OBJECTIVES: The WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients. METHODS: The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period. DISCUSSION: The trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients' recruitment and impacted their physical activity patterns. CONCLUSIONS: The present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).

The detrimental effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients.

AIMS: A reduction of habitual physical activity due to prolonged COVID-19 quarantine can have serious consequences for patients with cardiovascular diseases, such as heart failure. This study aimed to explore the effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients. METHODS AND RESULTS: We analysed the daily number of steps in 26 heart failure patients during a 6-week period that included 3 weeks immediately preceding the onset of the quarantine and the first 3 weeks of the quarantine. The daily number of steps was assessed using a wrist-worn accelerometer worn by the patients as part of an ongoing randomized controlled trial. Multilevel modelling was used to explore the effect of the quarantine on the daily step count adjusted for weather conditions. As compared with the 3 weeks before the onset of the quarantine, the step count was significantly lower during each of the first 3 weeks of the quarantine (P < 0.05). When the daily step count was averaged across the 3 weeks before and during the quarantine, the decrease amounted to 1134 (SE 189) steps per day (P < 0.001), which translated to a 16.2% decrease. CONCLUSIONS: The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period. Staying active and maintaining sufficient levels of physical activity during the COVID-19 pandemic are essential despite the unfavourable circumstances of quarantine.

Cystatin C may be better than creatinine for digoxin dosing in older adults with atrial fibrillation.

BACKGROUND: Patients taking digoxin are older with high probability of having low muscle mass, and current clinical practice in digoxin dosing relies only on estimated glomerular filtration rate from serum creatinine (eGFRcrea). The aim of the study is to compare eGFRcrea and estimated glomerular filtration rate from serum cystatin C (eGFRcys) in older adult patients with atrial fibrillation (AF) overdosed with digoxin. METHODS: A total of 80 consecutive patients overdosed with digoxin and 33 controls with AF from Department of Internal Medicine were included in the prospective observational study. The median of age of participants was 81 years in both the overdosed and the control group. The eGFRs were calculated using The Chronic Kidney Disease Epidemiology (CKD- EPI) equations using standardized methods for serum creatinine and cystatin C measurement. RESULTS: The median (IQR) of eGFRcrea was higher than that of eGFRcys (45 mL/min/1.73 m2 (35-59) vs 30 (21-38), respectively; P < .0001) in overdosed patients. The median (IQR) of eGFRcrea was higher than that of eGFRcys (61 mL/min/1.73 m2 (49-72) vs 40 (30-56), respectively; P < .0001) in control group of patients. Serum predose digoxin concentration in overdosed patients was inversely associated with eGFRcys (ρ = -0.26, P < .05). CONCLUSION: Physicians should consider GFR when changing digoxin dosing. eGFRcys was lower in both the overdosed and the control group. eGFRcys would lead to lower digoxin doses and thus prevent overdose.

Vitamin D supplementation dose needs to be higher in patients with inflammatory bowel disease: interventional study.

INTRODUCTION: Vitamin D (vitD) is a substance with an immunomodulatory effect. Its insufficiency has negative impact also on inflammatory bowel disease (IBD) where it is often present. The recommended daily intake for general population is 600 UI/day (units/day). What is the necessary dose for IBD patients remains unknown. The aim of the study was to verify whether the 2,000 IU/day of vitD is sufficient for maintaining sustained levels in these patients. METHODS: Patients with Crohns disease (CD) or ulcerative colitis (UC) were supplemented orally with 2,000 IU of cholecalciferol daily during winter time. The level of 25-hydroxyvitamin D (25OHD) was established at the beginning of substitution period (October to December) and in Month 4. Demographic data, Ca, P, parathormone levels, dose of vitD used, and patients compliance were observed. RESULTS: 108 patients with CD and UC (71/37) were analysed, out of them 51 females, average age 43.3 ± 16.2 years. The level of 25OHD increased from 60.2 ± 26.5 nmol/l to 68.1 ± 27.1 nmol/l (p < 0.001) during the period with the average substitution dose of vitD 1 858 ± 464 IU/day. 60.2 % of subjects complied with the recommended dosing of vitD. The dose of 1,820 IU vitD/day showed to be sufficient for maintaining sustained levels in the model. No changes of Ca, P serum levels occurred during observation period. CONCLUSIONS: Substitution doses of vitD recommended for general population are insufficient for IBD patients. A dose of up to 2,000/day, which is safe, is necessary to maintain normal levels of 25OHD. Noncompliance with the use of vitD is high.

Selective coronary angiography, percutaneous coronary intervention and asymptomatic peri-procedural myocardial injury.

BACKGROUND: While there have been a number of studies reporting the incidence and implications of elevated troponin levels after percutaneous coronary intervention (PCI), the body of information about the incidence, associations, and implications of elevated troponin levels following coronary angiography (CAG) is limited. MATERIALS AND METHODS: A total of 220 consecutive patients with stable coronary artery disease or intermediate or low-risk acute coronary syndrome without persistent ST-segment elevation (NSTE-ACS) were included in our study. High-sensitivity cardiac troponin I (hs-cTnI) levels were measured before and after coronary angiography (CAG) in patients with or without PCI and correlated with a number of clinical variables. RESULTS: Hs-cTnI elevations above the 99th percentile upper reference limit (URL), or above 20% of the initially positive, yet already declining values, were found in 60 (37.2%) patients after CAG and in 45 (76.2%) patients undergoing PCI. Significant correlations of hs-cTnI elevation were found with the following variables: volume of contrast, fluoroscopy time, dose-area product, amount of contrast agent injected directly into the coronary arteries, total time of balloon dilation and the number and total length of implanted stents (P<0.001 for all). CONCLUSION: While an asymptomatic elevation of hs-cTnI is a common finding after PCI, it does occur, quite surprisingly, also after CAG. Despite contradictory views regarding the clinical relevance of asymptomatic post-procedural elevated hs-cTnI levels, it is generally believed that a mild elevation is not associated with an increased risk. Still, it may pose a diagnostic quandary following a successful interventional procedure and even more so after an uncomplicated CAG. TRIAL REGISTRATION: Clinicaltrials.gov - NCT02960321.

[Palliative care in cardiology]. / Paliativní péce v kardiologii.

Chronic heart failure is a progressive disease with an increasing prevalence. In spite of all medical progress (or thanks to it), it is finally one of the most common causes of death. Palliative care is an approach aimed to improve the quality of life of patients and their families in cases of life-threatening illness. Therefore, the use of palliative care in cardiology is entirely relevant. Estimating the course and prognosis of a patient with chronic heart failure is difficult despite many prognostic tools. This makes it difficult to find the moment when palliative care is to begin. In general, gradual accentuation of treatment is recommended, focusing on the symptoms of the chronic progressive disease trajectory, and a reassessment of the benefit and potential adverse effects of conventional therapy. The main aspects of palliative care in cardiology are: 1. long-term communication with the patient and the family and their continuous education; 2. symptom-based treatment; 3. planning of advanced care; 4. A multidisciplinary team trying to meet all the patient's personality needs. Accepting palliative care as a part of complex care is a great challenge for the future of cardiology in the Czech Republic.Key words: heart failure, palliative care, cardiology.

The optimal bowel preparation intervals before colonoscopy: A randomized study comparing polyethylene glycol and low-volume solutions.

BACKGROUND & AIMS: The optimal duration of bowel preparation has only been assessed for polyethylene glycol (PEG). The aim of the study was to determine the intervals for achieving a satisfactory quality/tolerability of the preparation using PEG/ascorbic acid (PEGA) and sodium picosulphate/magnesium citrate (SPMC), and to compare them with 4L of PEG. METHODS: A randomized, endoscopist-blinded, multicentre study. The 612 outpatients referred to a colonoscopy, were prepared using PEG, SPMC, PEGA. The quality, tolerability, duration of the preparation, and the interval from the end of the preparation to the colonoscopy was assessed. RESULTS: Optimum duration of the preparation was similar for both PEG and SPMC (≥7.3 vs. ≥8.8 h, overall ≥8.4 h). Optimum interval to the colonoscopy was ≤11.8 h and did not differ between preparations (PEG, PEGA ≤ 11.8, SPMC ≤ 13.3 h). These times were the only predictors for a satisfactory preparation. The tolerability depends on the product type (SPMC) only. Timing of the preparation or the other factors had no impact on tolerability. CONCLUSION: The optimum intervals for bowel preparation are identical for all preparations. Satisfactory preparation is achived at the preparation length ≥8.4 h and the time to colonoscopy ≤11.8 h.

Effect of a 6-month pedometer-based walking intervention on functional capacity in patients with chronic heart failure with reduced (HFrEF) and with preserved (HFpEF) ejection fraction: study protocol for two multicenter randomized controlled trials.

BACKGROUND: Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chronic diseases, but it is unknown whether a pedometer-based intervention improves functional capacity and neurohumoral modulation in heart failure patients. METHODS: Two multicenter randomized controlled trials will be conducted in parallel: one in patients with chronic heart failure with reduced ejection fraction (HFrEF), the other in patients with chronic heart failure with preserved ejection fraction (HFpEF). Each trial will consist of a 6-month intervention with an assessment at baseline, at 3 months, at the end of the intervention, and 6 months after completing the intervention. Each trial will aim to include a total of 200 physically inactive participants with chronic heart failure who will be randomly assigned to intervention or control arms. The 6-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback). The primary outcome is the change in 6-min walk distance at the end of the 6-month intervention. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC risk score. DISCUSSION: To our knowledge, these are the first studies to evaluate a pedometer-based walking intervention in patients with chronic heart failure with either reduced or preserved ejection fraction. The studies will contribute to a better understanding of physical activity promotion in heart failure patients to inform future physical activity recommendations and heart failure guidelines. Trial registration The trials are registered in ClinicalTrials.gov, identifiers: NCT03041610, registered 29 January 2017 (HFrEF), NCT03041376, registered 1 February 2017 (HFpEF).

[Antithrombotic therapy and nonvariceal upper gastrointestinal bleeding]. / Antitrombotická lécba a nevarikózní krvácení do horní cásti gastrointestinálního traktu.

BACKGROUND: The incidence of acute upper gastrointestinal bleeding is about 85-108/100,000 inhabitants per year, nonvariceal bleeding accounts for 80-90%. Antiplatelet and anticoagulation treatment are the significant risk factors for upper gastrointestinal bleeding. OBJECTIVES: To evaluate the occurrence of upper gastrointestinal bleeding in the general community of patients in a county hospital. And to compare the role played by antiplatelet and anticoagulation drugs and other risk medication. DESIGN AND METHODS: Retrospective analysis of patients over 18 years of age who underwent endoscopy for acute upper gastrointestinal bleeding or anaemia (haemoglobin<100 g/l) with proved source of blood losses in upper gastrointestinal tract during a hospital stay in 2013 (from January to June). RESULTS: We included 111 patients of average age 69±15 years, men 60%. Nonvariceal bleeding accounted for 90% of the cases. None of the patients with variceal bleeding (10% of patients) took antiplatelet or anticoagulation therapy. There were 100 patients with nonvariceal bleeding of average age 70±15, 61% men. With the symptoms of acute bleeding (hematemesis, melena) presented in 73% of patients. The most frequent cause of bleeding was gastric and duodenal ulcer (54%). 32% of patients with nonvariceal bleeding had antiplatelets, 19% anticoagulants and 10% used nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors or corticosteroids. 30-days mortality of patients with nonvariceal bleeding was 11%, annual mortality was 23%. There was no significant difference in mortality, blood transfusion requirements or surgical intervention between the patients with antithrombotic agents and without them. 25% of patients (8 patients) using acetylsalicylic acid did not fulfil the indication for this treatment. CONCLUSION: Among the patients examined by endoscopy for symptomatic nonvariceal bleeding and/or anaemia (haemoglobin<100 g/l) significantly higher portions of patients are taking antiplatelet rather than anticoagulation therapy. This may be caused by greater use of these drugs in the population, but on the other hand it may reflect an association with greater risk of gastrointestinal bleeding. With regard to that, it is alarming, that there still exists a nonnegligible percentage of patients taking acetylsalicylic acid even though they do not meet the indication for the prescription according to the guidelines.

[Unusual intervention of native vessel in patient with coronary artery bypass]. / Neobvyklá intervence na nativní tepne u pacienta po aortokoronárním bypassu.

Coronary artery bypass grafting (CABG) is older method of revascluarization treatment of coronary artery disease (CAD) then percutaneous coronary intervention (PCI), but in some cases, especially in multivessel disease or chronic total occlusions, still used. Extending survival of patients with CAD increases number of recathetrizations and interventions namely in post-CABG subjects. Due to degenerative and atherosclerotic changes of bypasses, especially venous grafts, interventional cardiologists are forced to solve often complicated findings. In other cases patients are reoperated with increased risk. Our task describes unusual, technically challenging and somewhat risk PCI of native vessel through arterial bypass in post-PCI patient with significant angina.

Potential role of selected biomarkers for predicting the presence and extent of coronary artery disease.

INTRODUCTION: Since atherosclerosis may in part be an inflammatory disease, circulatory factors related to inflammation may be predictors of coronary artery disease. The aim of this study was to evaluate the association between the level of some circulating biomarkers and the extent of coronary artery disease. METHODS: Blood samples were taken from 128 patients with stable forms of coronary heart disease. Macrophage chemoattractant protein-1 (MCP-1), matrix-metalloproteinase-3 (MMP-3), soluble CD40 ligand (sCD40L) and soluble tumour necrosis factor receptor-2 (sTNFR2) were measured by ELISA. Coronary angiography and grading with the SYNTAX score followed. RESULTS: There was no significant interdependence of circulating MCP-1, sCD40L, sTNFR2 levels and SYNTAX score. MMP-3 levels were significantly different in subgroup with coronary artery disease (SYNTAX score > 0): 38.1 µg/l (13.6; 84.1) and subgroup without coronary artery disease (SYNTAX score = 0): 20.4 µg/l (13.1; 82.8), p=0.001. According to the Spearman correlation coefficient there was significant association between MMP-3 level and SYNTAX score (0.358, a=0.05). CONCLUSIONS: Our data suggest association between the extent of coronary artery disease and circulating MMP-3. We failed to demonstrate any association with the other investigated biomarkers.