Bahia Blanca

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

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.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the efficacy, safety, and pharmacokinetics of INM004 in children with Hemolytic Uremic Syndrome caused by Shiga toxin-producing Escherichia coli STEC-HUS. This study aims to assess how well INM004, when added to standard care, improves kidney function and reduces complications, mortality, and hospital stay in affected pediatric patients. Participants will be randomly assigned to receive either two doses of INM004, an Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin fragment, or two doses of a placebo solution. Each dose is given intravenously 24 hours apart, with infusion times adjusted based on body mass index. The study includes a 28-day acute phase and further assessments up to 90 days to monitor recovery and other health outcomes. During the study, children will undergo evaluations of kidney function, blood tests for markers of disease activity, and safety assessments. Researchers will measure the time to kidney function recovery as the primary outcome, along with mortality rates, dialysis needs, and hospital stay length. The trial lasts for at least 90 days, including close monitoring of health status and medication effects throughout this period.

Researchers are investigating whether a new management strategy for hypertension that combines usual care visits with the use of the ESH CARE App improves blood pressure control and related health outcomes compared to standard care. This one-year, randomized study aims to assess differences in office, home, and ambulatory blood pressure control, as well as cardiovascular and kidney-related measures in patients with uncontrolled hypertension. Participants are randomly assigned to one of two groups the usual care group, which receives standard three-monthly visits with therapy adjusted based on office blood pressure, and the POST-strategy group, which adds use of the ESH CARE App to communicate home blood pressure readings to a referral center. In the POST group, therapy adjustments occur every 15 days based on home measurements. Both groups undergo regular visits at baseline, three, six, and twelve months with clinical assessments, blood tests, urine tests, echocardiograms, ECGs, and ambulatory blood pressure monitoring. Throughout the study, participants measure home blood pressure regularly, with the POST group measuring twice weekly plus seven consecutive days before visits, and the usual care group measuring before baseline and study end. Researchers monitor blood pressure changes, heart structure, kidney function, and medication use to evaluate the effects of each strategy. The total participation lasts about one year, with detailed clinical and laboratory evaluations at scheduled intervals to assess treatment impact and safety.

Researchers are evaluating palazestrant OP-1250 compared to standard endocrine therapies for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy combined with a CDK46 inhibitor. This international phase 3 trial aims to assess the safety and effectiveness of palazestrant versus fulvestrant or aromatase inhibitors such as anastrozole, letrozole, or exemestane. Participants are randomly assigned to receive either palazestrant daily on a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or the standard-of-care endocrine therapy including fulvestrant administered on specific days or one of the aromatase inhibitors given daily on similar cycles. The trial includes an initial dose-selection period with about 120 participants, followed by a larger randomized phase with approximately 390 participants receiving the selected dose of palazestrant or standard treatment. Throughout the study, participants will be monitored for adverse events, dose adjustments, and drug discontinuations up to 16 weeks. Researchers will measure progression-free survival for up to two years and overall survival for up to four years after randomization. Regular assessments will include clinical evaluations and safety monitoring to observe the effects and tolerability of the treatments during the trial.

Researchers are evaluating the safety and effectiveness of the Vienna Aortic Valve SE System, a new self-expanding transcatheter heart valve, in patients with symptomatic severe aortic stenosis. This prospective, single-arm, multicenter trial includes up to 267 patients and follows them for up to five years after valve implantation. The study aims to gather important data beyond an initial feasibility study to better understand this devices performance over time. Participants will receive the Vienna Aortic Valve SE System through a transcatheter aortic valve implantation TAVI procedure. After implantation, patients will have 11 scheduled visits, including follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years. These visits allow researchers to monitor the devices safety and effectiveness throughout the study period. During the trial, participants will undergo clinical evaluations including assessments of mortality, valve function, and heart-related events. Quality of life and exercise capacity will also be measured. Monitoring includes checking for complications like bleeding or conduction problems requiring pacemakers. The study concludes after each participant completes their 5-year follow-up visit, providing long-term information on the valve systems outcomes.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.