Vila Velha

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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.

Researchers are evaluating the effects of therapeutic-dose heparin compared to usual care pharmacological thromboprophylaxis in patients hospitalized with community-acquired pneumonia CAP. This international, open-label, randomized controlled trial aims to understand if higher doses of heparin can improve outcomes by addressing inflammatory and thrombotic processes that contribute to respiratory, cardiac, and organ complications in CAP. The study builds on findings from COVID-19 patients, where therapeutic-dose heparin showed benefits in non-critically ill patients. Participants are randomly assigned to one of two groups. One group receives a daily therapeutic dose of low molecular-weight heparin LMWH or unfractionated heparin UFH for up to 14 days or until hospital discharge. The other group receives usual care with thromboprophylactic dose anticoagulation following local protocols, with doses not exceeding half the therapeutic level. The investigational arm prefers LMWH but may use UFH, especially in cases of renal compromise, with dosing tailored to patient weight and local standards. During the study, participants will be monitored for survival over 30 days as the primary outcome. Secondary outcomes include bleeding events, heparin-induced thrombocytopenia HIT, thrombotic events, invasive mechanical ventilation, mortality at multiple time points, hospital-free days, and health-related quality of life. The study involves hospital assessments, close monitoring of safety and clinical status, and tracking of various health measures up to 180 days, ensuring comprehensive evaluation of the treatments under study.

Researchers are developing a registry of Brazilian patients with hereditary cardiovascular diseases by combining clinical information and genetic data. The study aims to identify which genes are most commonly affected and the frequency of these genetic changes within this population. The registry will help advance understanding and healthcare for hereditary heart conditions in Brazils public health system. Participants will be interviewed during their routine medical visits, and their DNA will be collected using buccal swabs for whole genome sequencing. This observational study does not involve any treatment but focuses on gathering detailed genetic and clinical data to better characterize hereditary cardiovascular diseases. The study is planned to run for 30 months starting from April 2025. During the study, participants will provide information through interviews and give DNA samples for sequencing. Researchers will measure diagnostic yield, genetic diversity, and variant frequency over the 30 months. The study does not involve additional interventions beyond data and sample collection, and participants will continue their usual medical care throughout the study period.

This research aims to collect real-world clinical data on the Dominus4 Stent-Graft used for treating thoracic aortic diseases, such as thoracic aortic dissection. The study focuses on evaluating the safety and effectiveness of this endovascular device following its approved Instructions for Use. It is a multicenter, observational study involving patients who have undergone this treatment. Participants will receive the Dominus4 Stent-Graft device as part of their endovascular repair procedure for thoracic aortic diseases. The study will observe patients prospectively after their procedure, following them at scheduled intervals to gather information. There is no randomization or placebo group since this is a post-market observational study. During the study, participants will be monitored for early adverse events within one month after the procedure, which is the primary safety outcome. Additional assessments include device success during surgery, absence of device fracture, endoleaks, reintervention rates, and adverse events tracked up to five years. Participants need to be available for follow-up visits over the study period, which lasts several years, to collect comprehensive safety and efficacy data.