Clinical trials

Background: The 2021 European Society of Cardiology (ESC) Heart Failure Guidelines give a Class I recommendation for all patients with heart failure to be involved in a multidisciplinary heart failure care programme in order to reduce heart failure-related hospitalisations and mortality. In addition, Heart Failure Guidelines emphasize the strategic importance of self-care and learning related tasks for all heart failure patients in order to improve prognosis. The current ESC Heart Failure Guidelines provide clear instructions on what to teach patients as part of a patient education programme, but it does not provide clear guidance on exactly how to do this. However, the position statement published by the ESC Heart Failure Association in 2011 and updated in 2021 provides significant assistance in implementing patient education and self-care into daily practice. Aim of the study: To analyse the impact of a complex, structured heart failure patient education programme on the acquisition and retention of knowledge related to heart failure and self-care. Study design:The data of adult patients hospitalised for heart failure at the Heart Failure Unit of the Department of Adult Cardiology, Gottsegen National Cardiovascular Center and at the Division of Cardiology, Department of Cardiology, Faculty of Medicine, University of Debrecen, as well as adult patients treated at the Heart Failure Outpatient Clinics of each Institute - and their relatives - participated in a complex, structured heart failure patient education programme on a voluntary basis were retrospectively and prospectively assessed. The aims are: 1. To analyse the impact of the patient education programme on knowledge related to heart failure and self-care; 2. To analyse the impact of the patient education programme on the retention of knowledge related to heart failure and self-care; 3. To analyse the impact of the patient education programme on self-care and changes in the practice of daily self-care activities; 4. To examine the impact of the patient education programme on prognosis. Methodology and organisation of the study: Patients participate in a complex, structured heart failure patient education programme on a voluntary basis between June 1, 2023, and December 31, 2026. The data of these patients will be analysed. Patients and their relatives participate in an interactive program lasting approximately 60 minutes, led jointly by doctors from the Working Groups on Heart Failure and heart failure nurses. The aim of the complex patient education programme is to provide information on the most important and basic facts about heart failure, to teach self-care, and to learn how to recognise emergency conditions, in accordance with the current ESC Heart Failure Guidelines and the position statement of the ESC Heart Failure Association. After the patient education programme, patients and their relatives are provided with written information materials and diagrams summarising the main elements of self-care and strategically important messages presented during the programme, with an emphasis on emergency conditions. Patients complete a questionnaire before, after, and 3, 6, and 12 months after the patient education programme. Completing the questionnaire is voluntary and anonymous. The questionnaire includes basic patient data (e.g., age, highest level of education, previous follow-up for heart failure), IT skills necessary for telemedicine care and consultation, and basic information (e.g., use of computers, smart devices, and the internet). The investigators assess patients' basic knowledge and their understanding of emergency situations using a simple-choice 11-question questionnaire developed by the Working Group on Heart Failure of Gottsegen National Cardiovascular Center. The impact of the patient education programme on changes in daily self-care practices using a questionnaire before and after the patient education programme was also analysed. Self-care is also assessed using the internationally validated 9-item European Heart Failure Self-Care Behaviour Scale (EHFScB-9) before patient education programme and 3, 6, and 12 months after. The patient feedback (rated on a scale of 1 to 5) on the usefulness of the patient education programme and the extent to which it has expanded their knowledge of heart failure was also assessed. During data processing, the basic clinical characteristics of patients, their hemodynamic and laboratory parameters, drug and device therapy, and prognosis (hospitalisation, mortality) were also investigated.

The goal of clinical trial is to prospectively collect data to investigate the prevalence of arrhythmia in young patients diagnosed with mitral annular disjunction who have no indication for implantable cardioverter defibrillator (ICD) or implantable loop recorder (ILR) implantation according to the current guideline. The study population is young (age 18-60), the participating patients have mitral annular disjunction confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium. This patient population has an increased risk of ventricular arrhythmias and sudden cardiac death. The investigators plan to implant 20 BioMonitor IIIm ILRs over a year in patients with mild or uncertain symptoms (dizziness, palpitations) and no malignant arrhythmias. Aims of the study: 1. Screening of asymptomatic patients with MAD for arrhythmia. 2. In case of symptoms, to prove or exclude the underlying arrhythmia. BioMonitor IIIm ILR implantation is planned in the following patient population: 1. Inclusion of 20 patients with mitral annular disjunction confirmed by echocardiography and late gadolinium enhancement in the myocardium by MRI. 2. Only patients who do not meet the current indication for ICD or ILR implantation based on the current recommendation will be included in the study.

The investigators plan to use artificial intelligence to analyse vaginal ultrasound images of the uterine lining (endometrium) taken during routine IVF treatment, which may predict implantation success during IVF treatment. Participation in the study is voluntary, involves no additional testing or intervention beyond routine procedures, and consent can be withdrawn verbally or in writing at any time without cause or adverse consequences. Over a three-year period, the trial is expected to enrol approximately 1,500 patients between the ages of 18 and 40 who are indicated for IVF treatment and who volunteer for treatment. Patients enrolled in the study will not be required to attend more clinic visits during treatment than they would otherwise have to. During the trial, certain patient-specific data (age, indication for treatment, body mass index), stimulation-specific data (duration of stimulation, type and dose of drug, endometrial thickness), ultrasound scans and outcome-specific data (treatment failure, biochemical pregnancy, clinical pregnancy) will be collected. The data will be stored in a secure database. The data collected during the study will only be accessible to the professionals involved in the study and no information, including personal data, will be disclosed to third parties.