Clinical trials

Visceral obesity is a well-established risk factor for the development of chronic non-communicable diseases (NCDs). Epicardial fat tissue (EFT) is located on the surface of the myocardium and may directly affect cardiac function and contribute to structural and functional remodeling. According to the literature, increased EFT thickness is associated with a wide range of NCDs, disease severity, and prognosis. The aim of this study is to investigate the associations between EFT thickness and clinical and anamnestic parameters, as well as to evaluate the prognostic value of this parameter in patients aged 50-70 years from the Russian Federation, Kazakhstan, Uzbekistan, and Kyrgyzstan.

This is a prospective, non-randomized, observational cohort study conducted at the FSBI "NMRC TPM" of the Ministry of Healthcare of the Russian Federation. Left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation for preventing cardioembolic events in patients with atrial fibrillation. However, the optimal post-procedural antithrombotic regimen following LAAC remains unclear, with no consensus on evidence-based therapy. Given current trends in cardiology favoring reduced-intensity antithrombotic strategies, this study aims to contribute to the evidence base by evaluating whether LAAC followed by reduced-dose apixaban (2.5 mg BID) for 3 months with subsequent complete withdrawal of antithrombotic therapy is superior to long-term standard-dose DOAC therapy in patients with non-valvular atrial fibrillation.

This is a single-center randomized controlled trial evaluating the efficacy and safety of short (3 days) versus long (10 days) courses of intermittent hypoxic-hyperoxic training (IHHT) in patients with type 2 diabetes mellitus aged 50-74 years. Participants will be randomized into three groups: 3-day IHHT course (n≥100), 10-day IHHT course (n≥100), or control group receiving gas mixture with constant O2 21% for 10 days (n≥50). The primary outcomes are fasting glucose levels and HbA1c. Secondary outcomes include cardiovascular parameters, quality of life, cognitive function, and biological age.

Study aim is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.

Objective: to evaluate the effectiveness of using a food product, dry finely dispersed beetroot powder in a dose of 20 g, containing 800 mg of nitrate (NO3-), in relation to the regulation of blood pressure in men with hypertension who reached the target blood pressure level while taking optimal antihypertensive therapy. Characteristics of the study: randomized, open, and cross-sectional. Relevance of the study Currently, it is recognized that vasodilatory endothelial dysfunction due to impaired synthesis and bioavailability of endogenous nitric oxide (NO) is a characteristic change in patients with arterial hypertension (AH) and plays one of the key roles in the development and progression of this pathology. Nitrate (NO3-), contained in food products, the highest content of which is found in beetroot, is converted into NO in the body after consumption, which can have a positive effect on the state of the cardiovascular system and lead to a decrease in blood pressure. Indeed, this assumption has been confirmed in various clinical studies. The results of the conducted studies demonstrate the positive effect of beetroot juice enriched with NO3- on the functional parameters of the cardiovascular system, in particular, the level of SAD and DBP, vasodilator function, endothelium and arterial stiffness, both in patients with hypertension and conditionally healthy people. However, most of the studies conducted in this field either include a relatively small number of subjects with hypertension, or do not have a cross-sectional design, which is a limitation in formulating unambiguous conclusions about the positive effect of taking beetroot enriched with NO3- on lowering blood pressure in this category of patients. Moreover, the effect of beetroot juice on the functional state of the peripheral arterial bed (terminal muscular arteries, distributive and precapillary arterioles) remains unexplored, which, due to the increased bioavailability of NO by the vascular wall, may be expressed in a decrease in arterial stiffness, a decrease in smooth muscle cell tone (MMC) and a decrease in total peripheral vascular resistance, which will have a positive effect on tissue homeostasis. It is relevant to study the effect of course intake of beetroot enriched with NO3- on the functional state of all arterial links and regulation of blood pressure in patients with hypertension. Research materials and methods The study will be performed on the basis of the Laboratory of Microcirculation and Regional Blood Circulation of the Department of Fundamental and Applied Aspects of Obesity and the Center for Coordination of Fundamental Scientific Activities of the Federal State Budgetary Institution "NMIC TPM" of the Ministry of Health of the Russian Federation. The study is planned to include 60 men aged 18-60 years with hypertension who reached the target blood pressure level according to office measurement and daily blood pressure monitoring (SMAD) on the background of regular intake of AGT. Research design The study will consist of two screening stages and one main stage (Figure 1). Patients will be divided into 2 equal groups of 30 men using simple randomization using the closed envelope method. The first group will be assigned a one-week course of daily intake of dry fine beetroot powder in a dose of 20 g containing 800 mg of NO3- (food product), the second group will continue regular intake of AGT. After 7 days, the crossing will be performed: patients of the first group will continue to receive regular AGT, and patients of the second group will receive a food product. At each stage, all participants undergo blood pressure and heart rate (HR) measurements, anthropometry, basic research methods\* and SMAD. The total duration of the study will be 14-16 days.

Contrast-induced nephropathy (CIN) is a common complication in high-risk patients undergoing percutaneous coronary intervention (PCI) due to exposure to iodinated contrast agents. CIN is associated with increased morbidity, prolonged hospital stays, and higher healthcare costs. Current preventive strategies include adequate hydration and minimizing contrast volume; however, there is no universally effective pharmacological intervention. Recent studies suggest that inorganic nitrates can enhance renal perfusion, reduce oxidative stress, and improve endothelial function, potentially lowering the risk of CIN. This study aims to evaluate the efficacy and safety of a beet-derived inorganic nitrate-based food product for the prevention of CIN in high-risk patients undergoing PCI. This is a randomized, controlled, open-label clinical trial comparing two groups: 1. Intervention Group: Patients receiving the beet-derived inorganic nitrate-based food product for 5 days (starting 24 hours before PCI). 2. Control Group: Patients receiving standard medical care without additional nitrate supplementation. We hypothesize that the nitrate-based food product will significantly reduce the incidence of CIN compared to standard care. Additionally, we expect: 1. A lower increase in kidney injury biomarkers (NGAL, cystatin C) in the intervention group. 2. A slower decline or even improvement in eGFR at follow-up. 3. A potential reduction in MACE due to the vasoprotective effects of nitrates. 4. Improved quality of life scores (EQ-5D) in the intervention group. If successful, this study will provide new evidence supporting the use of dietary nitrates for renal protection and may contribute to the development of novel, cost-effective prevention strategies for CIN.

The primary purpose of this study is to evaluate possible association of some heterogeneous circulating biomarkers and anamnestic factors of pregnancy adverse course and outcomes with the prognosis of heart failure with preserved ejection fraction. The study population includes women aged 60-74 years with history of pregnancy with duration at least 20 weeks and diagnosed heart failure with preserved ejection fraction based on algorithm HFA-PEFF. The following pregnancy complications are assessed on the initial visit: gestational hypertension, preeclampsia, gestation diabetes mellitus and recently introduced as cardiovascular disease risk factors preterm delivery, stillbirth, miscarriage. This information is collected through a questionnaire which additionally includes questions about menopause and the circumstances of its onset. The data about comorbidities, results of laboratory and instrumental tests is collected from medical records. After the interview short physical examination is performed to measure anthropometric data and objective signs of congestion. In addition, medical Research Council Scale survey is conducted to assess the subjective severity of shortness of breath and a six-minute walking test to objectively evaluate the heart failure functional class. After inclusion in the study blood sampling is performed to measure the concentration of a number of biomarkers which are recognized as prognostically significant in context of heart failure: high-sensitivity troponin I, soluble suppression of tumorigenicity 2 protein, heat shock protein 27, cystatin C. As part of the study echocardiography is also performed with evaluation of left ventricular global longitudinal strain and left atrial strain to assess systolic and diastolic myocardium function. 12 months after the initial visit, participants are contacted by telephone. The data about newly diagnosed chronic non-communicable diseases, emergency hospitalization for any cause and major adverse cardiovascular events is collected. If there is no response from the research participant, the cause, including possible hospitalization or death, is determined by telephone contact with the participant's trusted person.