Campina Grande Do Sul

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

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 evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are studying the use of bempedoic acid alone or combined with ezetimibe in adult patients who have primary hypercholesterolemia both heterozygous familial and non-familial types or mixed dyslipidemia. This observational study aims to collect real-world data from Asian and Latin American patients to better understand the risks and benefits of these treatments, as current efficacy and safety information in these populations is limited. Participants in this study receive routine clinical care where they may be treated with bempedoic acid alone or its fixed-dose combination with ezetimibe. No experimental drugs are administered as this is a non-interventional study. The study follows patients for one year after starting the treatment to observe outcomes in their usual care setting. Throughout the one-year follow-up, researchers collect data on patient characteristics, adverse drug reactions, and adverse events related to the treatments. They also assess cardiovascular risk, cholesterol levels including LDL-C, inflammatory markers, uric acid levels, and the attainment of cholesterol goals. This information is gathered from medical records and routine clinical assessments to monitor the safety and effects of the treatments over time.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

This research aims to collect real-world data on the characteristics, management, healthcare use, and outcomes of patients living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It is an international observational registry that includes patients from many countries to better understand how these conditions are treated in everyday clinical practice. Participants in this registry are observed without receiving experimental treatments. Data are collected both retrospectively and prospectively using a cloud-based electronic case report form accessible to investigators and a scientific committee. The registry includes groups of patients with type 2 diabetes, hypertension, chronic kidney disease, or heart failure, either as their primary condition or as a coexisting condition. Patients provide information about their health status, treatments, and outcomes over time. Researchers collect data on demographics, disease characteristics, laboratory tests, treatments, healthcare visits, hospitalizations, and lifestyle factors. The study measures many outcomes such as blood sugar levels, kidney function, heart function, medication use, and health events over an average of three years. Participation is voluntary and ongoing, with data collection continuing until the study end date in 2030.

Researchers are investigating the impact of adding inclisiran to usual care compared to usual care alone on lowering LDL cholesterol LDL-C in patients hospitalized after an acute cardiovascular event such as a heart attack, ischemic stroke, or urgent coronary revascularization. This multi-country, open-label, randomized clinical trial focuses on patients stabilized and ready for discharge following such events. The study explores the real-world effects on LDL-C levels, patient-reported outcomes, and healthcare resource use. Participants are divided into two groups one receives usual care, which includes physical activity, diet changes, and standard cholesterol-lowering medications like statins and others the other group receives the same usual care plus inclisiran injections at baseline, 90 days, and 270 days. Usual care treatments vary by country but commonly involve statins and other cholesterol-lowering drugs. This phase 4 study measures the effectiveness of inclisiran added to usual care over approximately 11 months. During the study, participants will have assessments at baseline and at day 330 to measure changes in LDL-C and other outcomes such as the proportion of patients achieving specific LDL-C reduction goals. Researchers also track the timing of statin initiation during the study period. Patient health, adherence to treatment, and safety will be monitored throughout. The study concludes for each participant after the last visit and related assessments at day 330.

This research evaluates the long-term safety and effects of plozasiran in adults with hypertriglyceridemia HTG and severe hypertriglyceridemia SHTG. Participants must have completed prior related studies and meet specific health criteria, including controlled blood sugar levels HbA1c 10%. The study is designed as an open-label Phase 3 trial to extend understanding of this treatment in these populations. Participants will receive plozasiran injections under the skin approximately every three months for two years. They will continue following a low-fat diet according to local care standards. Some participants may join based on meeting additional criteria from previous studies, ensuring they fit the trials health requirements. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects and changes in blood triglyceride and cholesterol levels. Researchers will track various blood markers and cardiovascular events over 24 months. Safety and response to treatment will be closely observed throughout the trial period.

Researchers are evaluating whether low dose colchicine can reduce vascular events in patients with symptomatic peripheral artery disease PAD. This phase 3 randomized, double-blind, multicenter trial aims to prevent major adverse cardiovascular and limb events MACE and MALE such as heart attack, stroke, cardiovascular death, severe limb ischemia requiring intervention, or major vascular amputation. The study includes 6,150 participants and is sponsored by the Population Health Research Institute. Participants will be randomly assigned to receive either colchicine 0.5 mg daily or a placebo tablet that looks identical. Treatment lasts for the duration of the trial, which spans 3 to 5 years, including an active run-in period. The trial is designed to compare the effects of the colchicine drug against placebo in preventing serious vascular complications in PAD patients. During the study, participants will have regular assessments to monitor cardiovascular and limb health, including evaluations of major adverse events, hospitalizations, revascularizations, and quality of life. Researchers will collect data on outcomes like cardiovascular death, stroke, acute or chronic limb-threatening ischemia, and overall mortality over 3 to 5 years. Safety and adherence to the study medication will be monitored throughout the trial period, with follow-up visits to track health status and event occurrences.