Saratoga Springs

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

This research aims to evaluate the effects of the Alliance180 Program on both physical and psychological well-being in adults who are or were US Veterans, First Responders, and Front Line Healthcare Workers. The study focuses on how this program influences feelings of safety, autonomic functioning, and mental health indicators such as depression, anxiety, and trauma response. Participants are adults currently experiencing symptoms related to trauma exposure. All participants will undergo the same process as this is a single-arm pilot study. Initially, they will complete self-report questionnaires on demographics, safety perception, trauma experience, autonomic reactivity, anxiety, depression, and purpose in life during a baseline research session. Then, participants will take part in the 3-day Alliance180 Program, which includes a transformative equine experience designed to promote neuropsychological safety and trust. After finishing the program, participants will complete follow-up self-report assessments at 1 week, 1 month, 3 months, and 6 months. These assessments will measure safety perception, trauma experience, autonomic reactivity, anxiety, depression, and life purpose. The main outcomes focus on changes in anxiety and depression scores one month after the baseline. All data collection is conducted remotely through a secure online system.

Researchers are evaluating how a synbiotic supplement (Plexus4 Triplex), a commercially available probiotic, and a placebo affect the gut microbiome, cardiometabolic health, body weight, and body composition in healthy adults aged 18 to 60. The study aims to understand changes in gut bacterial counts, microbial diversity, short-chain fatty acids, inflammation markers, mucosal immunity, heart rate, blood pressure, vascular stiffness, blood glucose, lipids, and self-reported measures of fullness, gastrointestinal health, and mood. Participants will be randomly assigned to one of three groups receiving synbiotic, probiotic, or placebo supplements to be taken over 30 days. The study is double-blinded and placebo-controlled, comparing the effects of these dietary supplements on gut microbiome and heart-related health factors. The treatment period involves daily intake of the assigned supplement with no control for menstrual cycle phase, but documentation will be collected for statistical consideration. During the study, participants will undergo assessments at baseline, 15 days, and 30 days to measure gut microbial diversity and counts, short-chain fatty acid levels, and cardiometabolic parameters including heart rate, blood pressure, vascular stiffness, body weight, body composition, blood glucose, and lipid levels. Questionnaires on fullness, gastrointestinal health, and mood will also be completed. Safety and health history will be monitored, and participants must be relatively healthy and weight stable to take part.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are investigating whether the effects of dietary capsaicin on cardiovascular health differ between men and women. This study aims to understand how capsaicin influences nitric oxide bioavailability and key markers such as blood pressure, vascular function, and arterial stiffness. The knowledge gained will help guide future clinical trials focused on improving cardiovascular health using dietary approaches. Participants will take daily dietary capsules containing either capsaicin or a placebo for 6 weeks in a double-blind, randomized, placebo-controlled trial. The study will measure the impact of this intervention on blood pressure, arterial stiffness, and vascular function, considering sex-specific responses. Researchers will also monitor heart rate variability and capsaicin metabolism to understand the underlying mechanisms. Throughout the study, participants will undergo assessments at baseline, 24 hours, and 6 weeks, including measurements of blood pressure, vascular stiffness, heart rate and variability, flow mediated dilation, passive leg movement hyperemia, and near-infrared spectroscopy vascular occlusion tests. These evaluations will help determine how capsaicin affects cardiovascular function and nitric oxide availability over time.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.