Vila Velha

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are investigating a treatment approach for patients hospitalized with community-acquired pneumonia (CAP), a condition with high rates of illness and death. This phase 3 trial compares therapeutic-dose heparin versus usual care pharmacological thromboprophylaxis to see if it improves patient outcomes. The study focuses on preventing complications caused by blood clots and inflammation that can worsen respiratory and organ function in CAP patients. Previous findings in COVID-19 pneumonia suggest heparin might reduce disease progression and mortality, but its effects in non-COVID-19 CAP are unknown. Participants will receive either therapeutic-dose heparin, preferably a low molecular weight heparin (LMWH) like enoxaparin, dalteparin, or tinzaparin, dosed by patient weight unless contraindicated. Intravenous unfractionated heparin (UFH) may be used instead, especially for those with kidney issues, with dosing adjusted to specific blood clotting targets. The trial is open-label and randomized, with adaptive rules to monitor progress. Usual care pharmacological thromboprophylaxis is the comparator. Treatment and monitoring occur during hospital admission, anticipated to last at least 72 hours after randomization. During the study, patients are assessed for survival at 30 days and monitored for complications related to CAP. Researchers collect clinical data including oxygen use, laboratory tests, and adverse events, tracking safety and effectiveness. The study excludes patients with active COVID-19, recent bleeding, contraindications to anticoagulation, or those receiving critical care interventions. Overall participation depends on hospital stay length and clinical status, with follow-up to evaluate the primary outcome of survival within a month.

Researchers are conducting an observational study to create a registry of Brazilian patients with hereditary cardiovascular diseases by combining clinical data with genomic information. The study aims to identify which genes are most commonly affected and determine the frequency of these genetic changes in the population. Participants have hereditary cardiovascular conditions such as various types of cardiomyopathy, familial hypercholesterolemia, Marfan syndrome, and other related syndromes. Participants undergo whole genome sequencing using DNA collected from a buccal swab to analyze their genetic makeup. This sequencing serves as a diagnostic test to explore genetic diversity and variant frequency related to their conditions. The genetic information is collected as part of routine medical care visits at multiple centers within Brazil's Unified Health System. During the study, participants will be interviewed and provide clinical information for the registry. Researchers will measure outcomes including diagnostic yield, genetic diversity, and variant frequency 30 months after the study start. Participants must consent to genetic counseling and provide informed consent. The study focuses on collecting detailed clinical and genomic data to better understand hereditary cardiovascular diseases in Brazil.

Researchers are evaluating the safety and effectiveness of the Dominus4 Stent-Graft Endoprosthesis in treating thoracic aortic diseases. This real-world, post-market clinical trial is designed to collect data on patients receiving this device according to its approved instructions. The study will include 100 patients undergoing endovascular treatment for thoracic aortic conditions such as thoracic aortic dissection. Participants will receive the Dominus4 Stent-Graft, which is placed inside the thoracic aorta to repair the affected area through a minimally invasive procedure. The study follows a prospective design, monitoring patients after the device placement to assess outcomes. The treatment is conducted according to the product's official instructions for use. During the study, patients will be followed up to monitor safety, including early occurrence of any adverse events within one month after the procedure. Researchers will collect clinical data throughout the study duration to evaluate the device's performance and patient safety. Participants must be available for appropriate follow-up visits, and the study includes informed consent and monitoring throughout the treatment period.

Researchers are evaluating whether patients with ventilator-associated tracheobronchitis (VAT) in intensive care units benefit from a 7-day course of antibiotics compared to clinical observation without antibiotic treatment. This trial is a national, multicenter, single-blinded, randomized non-inferiority study aiming to determine if monitoring without antibiotics is as effective as antibiotic therapy for VAT, given the current uncertainty and conflicting guidelines about antibiotic use for this condition. Participants diagnosed with VAT will be randomly assigned to one of two groups. One group will receive standard care plus a 7-day antibiotic course, while the other group will have clinical observation without antibiotics unless they develop new organ dysfunction or infections other than VAT. The study focuses on comparing these two approaches to see if withholding antibiotics is noninferior in managing VAT. During the study, patients will be monitored for ventilator-free days within 28 days after randomization. Researchers will assess clinical status, chest imaging, and tracheal secretion cultures. Safety and treatment effects will be carefully tracked, with data analysis conducted in a blinded manner. The trial encompasses ICU patients who have been mechanically ventilated for at least 48 hours and meet specific clinical and laboratory criteria for VAT.