Predicting outcomes of the acute phase of COVID-19. High sensitive prognostic model, based on the results of the international registry "analysis of chronic non-infectious diseases dynamics after COVID-19 infection in adult patients" (ACTIV).

The aim of this study is to investigate the course of the acute period of COVID-19 and devise a prognostic scale for patients hospitalized. Materials and methods: The ACTIV registry encompassed both male and female patients aged 18 years and above, who were diagnosed with COVID-19 and subsequently hospitalized. Between June 2020 and March 2021, a total of 9364 patients were enrolled across 26 medical centers in seven countries. Data collected during the patients' hospital stay were subjected to multivariate analysis within the R computational environment. A predictive mathematical model, utilizing the "Random Forest" machine learning algorithm, was established to assess the risk of reaching the endpoint (defined as in-hospital death from any cause). This model was constructed using a training subsample (70% of patients), and subsequently tested using a control subsample (30% of patients). Results: Out of the 9364 hospitalized COVID-19 patients, 545 (5.8%) died. Multivariate analysis resulted in the selection of eleven variables for the final model: minimum oxygen saturation, glomerular filtration rate, age, hemoglobin level, lymphocyte percentage, white blood cell count, platelet count, aspartate aminotransferase, glucose, heart rate, and respiratory rate. Receiver operating characteristic analysis yielded an area under the curve of 89.2%, a sensitivity of 86.2%, and a specificity of 76.0%. Utilizing the final model, a predictive equation and nomogram (termed the ACTIV scale) were devised for estimating in-hospital mortality amongst COVID-19 patients. Conclusion: The ACTIV scale provides a valuable tool for practicing clinicians to predict the risk of in-hospital death in patients hospitalized with COVID-19.

Effectiveness and Safety of Fenofibrate in Routine Treatment of Patients with Hypertriglyceridemia and Metabolic Syndrome.

Background: Multiple trials have demonstrated the efficacy of fenofibrate for the management of dyslipidemia. Real-world evidence may provide important insights into the effectiveness and safety of fenofibrate in patients with metabolic syndrome and elevated triglyceride (TG) levels, but such evidence is currently scarce. MATERIALS AND METHODS: A non-interventional study was conducted among routine healthcare providers. Patients with TG levels of >2.3 mmol/L on stable statin therapy starting fenofibrate treatment were enrolled. Data on medical history, fenofibrate treatment, change in lipid levels, and C-reactive protein (CRP) were collected from medical records every 3 months for 6 to 7 months of observation. RESULTS: Overall, 988 patients receiving fenofibrate were enrolled (median age [95% CI] 60 [26.0-86.0] years), and 46.4% of the participants were females. Most patients had concomitant cardiovascular disease. A baseline TG level of 3.6 ± 1.5 mmol/L was reduced by 50.1% to 1.7 ± 0.58 mmol/L at 6 months of treatment (p < 0.001). Baseline non-high-density lipoprotein cholesterol (non-HDL-C) levels decreased by 33.7% at 6 months. Total cholesterol and low-density lipoprotein levels by the end of follow-up were reduced by 24.7 and 25.5% (p < 0.001 for both). C-reactive protein level decreased more than 39% from baseline. CONCLUSIONS: Fenofibrate in a real-world setting significantly reduced TG, LDL-C, and non-HDL-C levels. In addition, a C-reactive protein level reduction of 39% was achieved.

Impact of heart failure on all-cause mortality in COVID-19: findings from the Eurasian International Registry.

AIMS: To study all-cause mortality in patients hospitalized with COVID-19 with or without chronic heart failure (CHF) during hospitalization and at 3 and 6 months of follow-up. METHODS AND RESULTS: The international registry Analysis of Comorbid Disease Dynamics in Patients with SARS-CoV-2 Infection (ACTIV) was conducted at 26 centres in seven countries: Armenia, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russian Federation, and Uzbekistan. The primary endpoints were in-hospital all-cause mortality and all-cause mortality at 3 and 6 months of follow-up. Of the 5616 patients hospitalized with COVID-19, 917 (16.3%) had CHF. Total in-hospital mortality was 7.6%. In-hospital mortality was higher in patients with CHF than in patients without a history of CHF [17.7% vs. 4.0%, P < 0.001; odds ratio (OR) 4.614, 95% confidence interval (CI) 3.633-5.859; P < 0.001]. The risk of in-hospital all-cause mortality correlated significantly with the severity of CHF; specifically, the risk of in-hospital all-cause mortality was greater for patients in New York Heart Association functional classes III and IV (OR 6.124, 95% CI 4.538-8.266; P < 0.001 vs. patients without CHF) than for patients in functional classes I and II (OR 2.446, 95% CI 1.831-3.267, P < 0.001 vs. patients without CHF). The risk of mortality in patients with ischemic CHF was 58% higher than in patients with non-ischaemic CHF [OR 1.58 (95% CI 1.05-2.45), P = 0.030]. In the first 3 months of follow-up, the all-cause mortality rate in patients with CHF was 10.32%, compared with 1.83% in patients without CHF (P < 0.001). At 6 months of follow-up, NYHA classes II-IV was a strong risk factor for all-cause mortality [OR 5.343 (95% CI 2.717-10.508); P < 0.001]. CONCLUSIONS: Hospitalized COVID-19 patients with CHF have an increased risk of in-hospital all-cause mortality, which remains high 6 months after discharge.

Use of Digital Technology Tools to Characterize Adherence to Prescription-Grade Omega-3 Polyunsaturated Fatty Acid Therapy in Postmyocardial or Hypertriglyceridemic Patients in the DIAPAsOn Study: Prospective Observational Study.

BACKGROUND: Maintaining sustained adherence to medication for optimal management of chronic noninfectious diseases, such as atherosclerotic vascular disease, is a well-documented therapeutic challenge. OBJECTIVE: The DIAPAsOn study was a 6-month, multicenter prospective observational study in the Russian Federation that examined adherence to a preparation of highly purified omega-3 polyunsaturated fatty acids (Omacor) in 2167 adult patients with a history of recent myocardial infarction or endogenous hypertriglyceridemia. METHODS: A feature of DIAPAsOn was the use of a bespoke electronic patient engagement and data collection system to monitor adherence. Adherence was also monitored by enquiry at clinic visits. A full description of the study's aims and methods has appeared in JMIR Research Protocols. RESULTS: The net average reduction from baseline in both total and low-density lipoprotein cholesterol was approximately 1 mmol/L and the net average increase in high-density lipoprotein cholesterol was 0.2 (SD 0.53) mmol/L (P<.001 for all outcomes vs baseline). The mean triglyceride level was 3.0 (SD 1.3) mmol/L at visit 1, 2.0 (SD 0.9) mmol/L at visit 2, and 1.7 (SD 0.7) mmol/L at visit 3 (P<.001 for later visits vs visit 1). The percentage of patients with a triglyceride level <1.7 mmol/L rose from 13.1% (282/2151) at baseline to 54% (1028/1905) at the end of the study. Digital reporting of adherence was registered by 8.3% (180/2167) of patients; average scores indicted poor adherence. However, a clinic-based enquiry suggested high levels of adherence. Data on health-related quality of life accrued from digitally engaged patients identified improvements among patients reporting high adherence to study treatment, but patient numbers were small. CONCLUSIONS: The lipid and lipoprotein findings indicate that Omacor had nominally favorable effects on the blood lipid profile. Less than 10% of patients enrolled in DIAPAsOn used the bespoke digital platform piloted in the study, and the level of self-reported adherence to medication by these patients was also low. Reasons for this low uptake and adherence are unclear. Better adherence was recorded in clinical reports. TRIAL REGISTRATION: ClinicalTrials.gov NCT03415152; https://clinicaltrials.gov/ct2/show/NCT03415152.

Digital Technology Tools to Examine Patient Adherence to a Prescription-Only Omega-3 Polyunsaturated Fatty Acid Therapy To Mitigate Cardiovascular Risk: Protocol for a Prospective Observational Study and Preliminary Demographic Analysis.

BACKGROUND: Sustained adherence and persistence with prescription medications is considered essential to achieve maximal treatment benefit for patients with major chronic, noncommunicable diseases such as hyperlipidemia and lipid-associated cardiovascular disease. It is widely documented, however, that many patients with these conditions have poor long-term adherence to their treatments. The population of Russia is affected by poor adherence in the same ways as populations elsewhere and continues to have high rates of cardiovascular disease. OBJECTIVE: The purpose of this study was to examine patient adherence to a prescription-only preparation of highly purified omega-3 polyunsaturated fatty acids (1.2 to 1 eicosapentaenoic acid to docosahexaenoic ratio, 90% purity) in a large sample of patients at risk for cardiovascular diseases using digital technology to monitor patient behavior and as an outreach facility for patient education and engagement. METHODS: We conducted a 6-month prospective observational study (DIAPAsOn) at >100 centers in the Russian Federation. A bespoke electronic data capture and patient engagement system were developed with a well-established Russian technology supplier that enables information obtained during clinic visits to be supplemented by remote patient self-reporting. Other aspects of the program included raising patients' awareness about their condition via educational materials available in personal patient accounts in the electronic system. RESULTS: From an initial cohort of 3000 patients, a safety population of 2572 patients (age: mean 60 years) with an equal proportion of men and women has been characterized. There was widespread concomitant cardiovascular pathology and commensurate use of multiple classes of cardiovascular medication, notably lipid-modifying and antihypertensive drugs. The program was completed by 1975 patients, of whom 780 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for secondary prevention after myocardial infarction and 1195 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for hypertriglyceridemia. Data collection and analysis have been completed. CONCLUSIONS: DIAPAsOn will provide insights into patient adherence with prescription-grade omega-3 polyunsaturated fatty acid therapy and perspectives on the role of mobile technology in monitoring and encouraging adherence to therapy.

Effects of ferric carboxymaltose on hospitalisations and mortality rates in iron-deficient heart failure patients: an individual patient data meta-analysis.

AIMS: Iron deficiency (ID) is a common co-morbidity in patients with heart failure (HF) and has been suggested to be associated with poor prognosis. Recently completed double-blind randomised controlled trials (RCTs) studying HF patients with ID have shown improvements in functional capacity, symptoms and quality of life when treated with i.v. ferric carboxymaltose (FCM). This individual patient data meta-analysis investigates the effect of FCM vs. placebo on recurrent hospitalisations and mortality in HF patients with ID. METHODS AND RESULTS: Individual patient data were extracted from four RCTs comparing FCM with placebo in patients with systolic HF and ID. The main outcome measures were recurrent cardiovascular (CV) hospitalisations and CV mortality. Other outcomes included cause-specific hospitalisations and death. The main analyses of recurrent events were backed up by time-to-first-event analyses. In total, 839 patients, of whom 504 were randomised to FCM, were included. Compared with those taking placebo, patients on FCM had lower rates of recurrent CV hospitalisations and CV mortality [rate ratio 0.59, 95% confidence interval (CI) 0.40-0.88; P = 0.009]. Treatment with FCM also reduced recurrent HF hospitalisations and CV mortality (rate ratio 0.53, 95% CI 0.33-0.86; P = 0.011) and recurrent CV hospitalisations and all-cause mortality (rate ratio 0.60, 95% CI 0.41-0.88; P = 0.009). Time-to-first-event analyses showed similar findings, with somewhat attenuated treatment effects. The administration of i.v. FCM was not associated with an increased risk for adverse events. CONCLUSIONS: Treatment with i.v. FCM was associated with a reduction in recurrent CV hospitalisations in systolic HF patients with ID.

Collagen accumulation and dysfunctional mucosal barrier of the small intestine in patients with chronic heart failure.

Chronic heart failure is a systemic disease with a devastating prognosis, which affects many organ systems other than the cardiovascular system. A total of 45 Chronic heart failure patients of ischemic etiology and 18 control subjects aged 45-65 years were recruited. All subjects underwent a physical examination by a qualified physician, echocardiography, an evaluation of the trophological status (including height and weight assessment) and net-of-fat body mass (NFBM) determination, an evaluation of intestinal functional activity based on fat and protein excretion with feces, and biopsy examination from the small intestine (see below). For all of them were performed functional tests of the small intestine and morphological examination of the small intestine and biopsy collection. Staining for collagen content of the mucosal wall showed that collagen content differed significantly between the four cohorts studied. In fact, relative collagen content was highest in advanced stages of the disease. However, patients with cardiac cachexia displayed even higher relative amounts of collagen than those of the same functional class without cardiac cachexia. Both fat loss and protein loss with the feces correlated with relative collagen area.