Bowie

Researchers are evaluating a personalized management strategy for people with symptoms suggesting coronary artery disease (CAD). The study compares this strategy, which uses AI-based software to analyze coronary plaque from CT scans, against the usual care based on current guidelines. The goal is to see if this new approach improves diagnosis certainty, risk factor control, and referral efficiency for invasive coronary angiography with appropriate percutaneous coronary intervention (PCI). This is a prospective, randomized, open-label trial focusing on symptomatic patients suspected of having CAD. Participants assigned to the personalized management group will undergo a coronary CT angiography (CCTA) at the start. The images from these scans are processed using Cleerly Labs and Cleerly ISCHEMIA software to assess coronary plaque. This information is used to guide medical and interventional treatment decisions. The usual care group will receive standard diagnostic and treatment approaches based on American Heart Association/American College of Cardiology guidelines. During the study, which lasts about one year, researchers will monitor participants to evaluate the effectiveness and efficiency of these management strategies. They will measure outcomes such as improved diagnosis certainty, better control of CAD risk factors, and more appropriate use of invasive procedures like PCI. Safety and adherence will also be followed throughout the study period to understand the overall impact of the personalized approach compared to usual care.

Researchers are evaluating a new approach to prevent cardiovascular events in patients at increased risk due to age and conditions like type 2 diabetes, prediabetes, or metabolic syndrome but without known symptomatic cardiovascular disease. The study compares a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy with standard risk factor-based care to see if the former can better reduce cardiovascular events. The Cleerly system uses imaging to visualize and quantify coronary artery disease and guides personalized treatment and education based on this assessment. The trial uses the Cleerly CAD Staging System device, which employs a proprietary algorithm to detect and stage coronary artery disease and generate a risk score to guide treatment decisions. Participants receive either this stage-based care or the usual care based on traditional risk factors. The study is prospective, randomized, and pragmatic, designed to follow patients over an average of 3.5 years to compare cardiovascular event outcomes between these two care approaches. Participants will be monitored through cardiovascular event tracking throughout the study period. Data collected includes imaging results, risk scores, and treatment adherence to evaluate the impact of the care strategies. The primary outcome is the comparison of cardiovascular event risk between the Cleerly stage-based care and risk factor-based care groups. The study also includes ongoing safety monitoring and personalized management by a cardiologist-led team via digital communication devices.

This research aims to assess the effectiveness and safety of eloralintide in adults with moderate to severe obstructive sleep apnea who are also obese or overweight. The study is organized under a master protocol called YDAO, which supports two separate studies: YSA1 for participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy, and YSA2 for those who have been using PAP therapy for at least three months and intend to continue it during the study. This is a Phase 3 randomized, double-blind, placebo-controlled trial focused on this specific population. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once weekly. They will be assigned to one of two groups based on their current PAP therapy use: those not using PAP (YSA1) and those continuing PAP (YSA2). The study treatment and observation will last about 76 weeks, allowing detailed evaluation over time. During the study, participants will undergo assessments including polysomnography to measure the apnea-hypopnea index (AHI) and body weight changes from baseline to week 64. Researchers will monitor weight, sleep apnea severity, and safety throughout the trial. The long participation period includes screening, treatment, and follow-up to capture comprehensive data on eloralintide’s effects and tolerability.

Researchers are evaluating the safety and effectiveness of solbinsiran in reducing triglycerides and other fat-related measures in adults with severe hypertriglyceridemia. This phase 2 study compares solbinsiran to a placebo to better understand its potential benefits and risks in this condition. Participants will receive two subcutaneous injections of either solbinsiran or a placebo. The study is randomized and double-blind, meaning neither the participants nor the researchers know who receives the actual drug or placebo during the treatment period. Participants will be monitored for changes in their triglyceride levels from baseline through weeks 16 to 24. The study tracks safety and efficacy by measuring lipid changes and observing any side effects. The total duration of participation includes screening and treatment phases with regular assessments throughout the study.

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.

This research aims to evaluate the safety and effects of the study medicine PF-07328948 for adults with heart failure. It focuses on how this medicine works compared to a placebo in people who are already using standard heart failure treatments that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. The trial is a Phase 2 study designed to better understand if PF-07328948 is safe and effective for managing heart failure symptoms and improving patients' health. Participants will be randomly assigned to receive either placebo tablets or one of three doses of PF-07328948 (low, medium, or high dose). All medications are taken once daily by mouth for 36 weeks. The treatment period is followed by ongoing study visits to monitor participants. The study involves 15 visits over about 48 weeks, with 10 visits at the study site and 5 visits conducted remotely by phone. During the study, researchers will assess participants at the start and after 36 weeks by measuring clinical events, changes in the six-minute walk test distance, and changes in heart failure symptoms using the Kansas City Cardiomyopathy Questionnaire. Safety and treatment effects will be closely monitored through these visits and assessments throughout the study period.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are investigating alcohol use among U.S. adolescents and evaluating two types of care to reduce alcohol use and related problems in this population. The study compares a brief motivational interviewing-based alcohol intervention (BMAI) alone to BMAI combined with a smartphone app-delivered mindfulness training (MT). This pragmatic, randomized, controlled trial is conducted in pediatric primary care clinics within a regional health network serving a racially and ethnically diverse urban and suburban youth population. The study also explores patient and stakeholder perspectives, barriers and facilitators to intervention delivery, and factors affecting treatment response over a one-year follow-up period. Participants receive a face-to-face brief motivational interviewing-based alcohol intervention delivered by pediatric clinicians during routine or follow-up visits. This intervention includes one or more sessions involving structured feedback, advice, and goal setting to support behavior change. In addition, participants in the combined treatment group receive eight weeks of mindfulness training through the Healthy Minds Program smartphone app, which offers self-guided meditation and mindfulness practices focused on breath and body awareness and emotion noting. After the initial eight weeks, participants have open access to all app modules to explore additional mindfulness exercises during follow-up. Throughout the study, researchers assess alcohol use over the past 30 days at multiple time points up to 12 months. They also evaluate how acceptable the interventions are to adolescents, caregivers, and providers using questionnaires and interviews. Provider reports identify implementation barriers and facilitators at baseline and follow-up. The study collects detailed information on participant experiences, adherence to interventions, and factors that may influence outcomes. Safety and treatment effectiveness are monitored, with the total participation lasting one year.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.