Winchester

This research aims to evaluate how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. The study compares different doses of CDR132L to a placebo, with treatment assignment determined randomly. It is a phase 2, multicenter, randomized, double-blind, placebo-controlled trial sponsored by Novo Nordisk AS, lasting about 60 weeks. Participants will receive intravenous infusions of one of three doses of CDR132L or placebo once every 4 weeks for 48 weeks. Alongside the study drug or placebo, participants will continue their individually adapted guideline-directed standard of care therapy for heart failure. This treatment period is followed by an extension phase to monitor safety and efficacy. During the study, participants will undergo assessments including measuring the change in normalized microRNA-132-3p levels from baseline to week 24, as well as cardiac magnetic resonance imaging to evaluate heart structure changes and blood tests like NT-proBNP levels. Safety is monitored by recording adverse events up to week 60. The total participation duration is approximately 60 weeks, involving regular infusions and follow-up visits.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

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 safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

This research aims to learn about the safety and effects of the study medicine PF-07328948 for adults with heart failure. The study evaluates whether PF-07328948 is safe and effective compared to a placebo in people who already take standard heart failure medicines including SGLT2 inhibitors. It is a phase 2 randomized, double-blind, placebo-controlled trial sponsored by Pfizer. Participants will take either placebo tablets or one of three doses of PF-07328948 tablets once daily by mouth for 36 weeks. The study includes four groups placebo, low dose, medium dose, and high dose of PF-07328948. Treatment lasts 36 weeks, followed by monitoring and assessments. Participants will be involved for about 48 weeks with 15 visits to the study clinic, of which 5 may be performed at home by phone and 10 in person. Researchers will assess clinical events, 6-minute walk test distance, and heart failure symptom scores at baseline and week 36. Safety will be monitored through adverse event reporting up to week 40. Various questionnaires and physical tests will track health status and treatment effects throughout the study.

Heart failure is a chronic condition that often affects patients mental health, with about half experiencing linked issues like stress, depression, and anxiety. Despite this connection, mental health support is not routinely part of heart failure care. This study evaluates the FRAME intervention, which was co-designed by researchers, healthcare providers, health system decision-makers, and patient partners to improve mental health awareness and support within cardiac care pathways in Ontario, Canada. The study uses a pretest-posttest hybrid 1 model to assess feasibility at pilot clinical sites such as family medicine clinics, cardiac rehabilitation clinics, specialist clinics, and emergency departments. The FRAME intervention is a multi-component web tool designed to help patients, caregivers, and healthcare providers recognize and manage mental health alongside heart failure. It includes educational materials, conversational aids for discussing mental health, self-management activity suggestions like nutrition and exercise tips, resource maps, and a provider tool to guide conversations and referrals. Participants who complete the intake survey receive the FRAME intervention via email in April 2026. Participants will be involved in baseline data collection through surveys, followed by the intervention and up to six months of follow-up evaluations. Researchers will monitor the frequency of mental health conversations, engagement in health-seeking behaviors, and confidence and knowledge related to mental health discussions. These outcomes will be measured through surveys and semi-structured interviews, aiming to inform a future larger cohort study and broader integration of the FRAME tool into cardiac care.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Syncope, a sudden loss of consciousness, often leads to emergency department ED visits. While many cases are harmless, some are caused by serious heart or other medical problems that might not be clear during the initial ED visit. Researchers have developed the Canadian Syncope Risk Score CSRS to help identify patients who need further tests, monitoring, or hospital admission. This study tests how well the CSRS-based recommendations work in real-world ED settings to improve patient safety and reduce unnecessary hospital stays and ED waiting times. This study involves 16 emergency departments across Canada in a stepped wedge cluster randomized trial lasting 16 months per batch. Initially, all EDs use their usual care for three months, then gradually switch to using the CSRS-based recommendations in random order, with two EDs changing every three months. The CSRS approach includes careful clinical evaluation, use of specific tests like troponin or CT scans, risk assessment at the end of the ED visit, providing patient information, and arranging 15-day outpatient heart monitoring for medium and high-risk patients. ED doctors apply these steps during patient care. Participants include adults who come to the ED within 24 hours after a syncope episode. Researchers will measure hospitalization rates, time spent in the ED before disposition, death rates up to one year, return ED visits, and how well doctors adopt and follow the CSRS recommendations. Data will be collected throughout the trial to assess both healthcare efficiency and patient safety. The study will last until 2026, with ongoing monitoring of outcomes and processes.