Search Bar & Filters
Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating a combination therapy of finerenone plus empagliflozin compared to usual care in patients hospitalized with heart failure. This international, randomized, controlled, open-label trial aims to assess the effectiveness and safety of this early, intensive treatment approach in managing heart failure during and after hospitalization. Participants will either receive the combination of oral finerenone and empagliflozin or continue with usual care management. The study is designed to compare these two approaches to determine their impact on clinical outcomes. The trial includes a treatment period with these medications given alongside usual management during hospitalization and follow-up. During the study, participants will be monitored over six months for clinical benefits and safety outcomes such as serious adverse events and adverse events leading to discontinuation. Researchers will assess heart failure events, symptom changes using the Kansas City Cardiomyopathy Questionnaire, and time to death or heart failure events. Study visits and evaluations will track participant health and response to treatment over this period.
Actively Recruiting
Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.
Actively Recruiting
Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.
Actively Recruiting
Healthcare-associated infections HAIs are a significant issue in intensive care units ICUs, often caused by environmental contamination with multidrug-resistant organisms that remain despite regular cleaning. Researchers are evaluating two advanced disinfection methodshydrogen peroxide aerosolization and ultraviolet-C lightto reduce this contamination. This cluster-randomized, crossover trial will be conducted in 12 Brazilian ICUs to compare these methods with usual surface disinfection practices. The trial includes three sequential cleaning strategies for each ICU usual surface disinfection alone usual disinfection followed by hydrogen peroxide aerosolization at 7.9% concentration applied inside a protective tent during terminal cleaning of beds and usual disinfection followed by automated ultraviolet-C irradiation applied under the same tent. The protective tent is used to prevent exposure of adjacent beds and ICU areas to the disinfecting agents. Participants will be all patients aged 18 years and older admitted to these ICUs. Researchers will measure antimicrobial use at the ICU level over three months, daily defined doses per 100 patient-days, and secondary outcomes such as rates of HAIs, contamination by multidrug-resistant organisms, specific infections like ventilator-associated pneumonia, bloodstream infections, urinary tract infections, and ICU length of stay costs. Safety and effectiveness of surface disinfection methods will be monitored throughout the study.
Actively Recruiting
Researchers are conducting an observational, prospective, multicenter cohort study to evaluate patients with severe and very severe Chronic Obstructive Pulmonary Disease COPD in Brazil. The study focuses on patients classified according to the GOLD 2024 guidelines, exploring how COPD severity relates to exacerbation rates, disease progression, complications, and mortality. This study aims to provide national data on this specific subgroup of COPD patients across different Brazilian regions with varying environmental exposures and genetic backgrounds. This non-interventional study will include patients from eight medical centers representing all five regions of Brazil, including teaching and tertiary hospitals. Participants will be enrolled consecutively and followed for 12 months. The study involves on-site visits at enrollment, 6 months, and 12 months, with tele-consults at 3 and 9 months to collect clinical data, especially regarding exacerbations. Participants will undergo evaluations during scheduled visits and tele-consults, with data collected and reviewed by the studys adjudication team. Researchers will measure outcomes such as the incidence of hospitalizations, exacerbations, mortality, vaccination rates, and lung neoplasia over approximately one year. The study emphasizes gathering comprehensive clinical information through direct and remote contacts to understand COPD progression and related health events.