Clydebank

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 the safety, tolerability, and potential effectiveness of multiple subcutaneous injections of APL-9796 in adults with pulmonary hypertension PH in this phase 2, open-label dose escalation trial. The study focuses on adults diagnosed with WHO Group 1 Pulmonary Arterial Hypertension PAH and optionally includes adults with WHO Group 3 PH associated with interstitial lung disease PH-ILD. The trial also monitors whether the body produces antibodies against APL-9796. The study is conducted in two parts with different participant groups. Part A involves up to 36 adults with WHO Group 1 PAH receiving one of three planned dose levels of APL-9796, evaluated sequentially in cohorts of four participants. An optional Part B may include up to 12 adults with WHO Group 3 PH-ILD, with initiation decided by a Safety Review Committee. The treatment is given as subcutaneous injections, and dose levels are adjusted based on ongoing safety data. Participants will be assessed through various evaluations including telemetry parameters, six-minute walk tests, NT-proBNP blood tests, and quality of life questionnaires from baseline through day 169. Pharmacokinetics and immune response to APL-9796 will be monitored at regular visits approximately every 28 days until day 169, with additional follow-ups on days 254, 339, and 508. The primary outcome focuses on the incidence of treatment-emergent adverse events over about two years, ensuring thorough safety and tolerability monitoring throughout the study.

Researchers are evaluating the outcomes of different coronary artery bypass grafting techniques in women with heart disease. The trial compares multiple arterial grafting MAG to single arterial grafting SAG to see if using multiple arterial grafts improves major heart and brain-related events and quality of life. This international randomized clinical trial includes 2,300 women to assess differences in survival, stroke, heart attacks, repeat surgeries, and hospital readmissions, as well as physical and mental health. Participants will be randomly assigned to one of two groups. One group receives a single arterial graft using the left internal thoracic artery plus additional venous grafts. The other group receives multiple arterial grafts, including the left internal thoracic artery and at least one other arterial graft such as the right internal thoracic artery or radial artery, with possible additional arterial grafts. The study uses the infrastructure of an existing trial and follows patients for at least 2.5 years after surgery. During the study, researchers collect data on major adverse cardiac and cerebrovascular events, along with quality of life measured by general and disease-specific questionnaires. Physical and mental health symptoms are also assessed. Follow-up includes tracking deaths, strokes, heart attacks, repeat procedures, and hospital stays. The trial aims to provide detailed information on outcomes and quality of life in women undergoing coronary bypass surgery over a long-term period.

Researchers are investigating a new approach to treat patients who have had a heart attack, specifically acute anterior ST-segment elevation myocardial infarction STEMI. This condition can cause serious damage to the heart muscle, leading to heart failure and early death. Despite many studies, few new treatments have shown success in preventing heart failure after a heart attack. This trial aims to explore the safety, feasibility, and possible benefits of increasing blood oxygen levels after the usual treatment. The standard treatment involves reopening the blocked heart artery through a procedure called primary percutaneous coronary intervention PCI using access via the wrist. After this, patients are randomly assigned to receive either supersaturated oxygen therapy or a sham procedure for one hour. Supersaturated oxygen therapy uses extra oxygenated blood infused back into the treated artery through the wrist, while the sham group undergoes a similar procedure without the oxygen infusion. Both groups will be monitored under blinded conditions to ensure unbiased results. Participants will undergo various assessments including blood tests, coronary angiography, heart MRI scans at 2-5 days and again at 3 months, and health questionnaires. Coronary microvascular function will be measured before and after the treatment or sham procedure. Follow-up visits will continue for up to one year, with health records monitored longer term. The main outcome measured is a heart-related blood marker at 3 months, along with secondary outcomes including heart function, infarct size, quality of life, and safety events.

This research investigates whether personalized medical treatment guided by a special diagnostic procedure during invasive coronary angiography can improve symptoms, wellbeing, cardiovascular risk, and clinical outcomes in patients with angina but no significant blockage in their coronary arteries. It focuses on patients with ischaemic heart disease, particularly those with angina without obstructive coronary artery disease INOCA, a condition affecting the small vessels of the heart. The trial builds on earlier pilot studies that suggested this approach could improve quality of life and symptom control by tailoring diagnosis and treatment more precisely. Participants undergo functional coronary angiography with a guidewire-based interventional diagnostic procedure IDP that measures coronary vascular function to classify patients into specific diagnosis groups, such as microvascular or vasospastic angina. Eligible patients are randomized into two groups one where IDP results are disclosed to clinicians to guide treatment, and another where IDP is performed but results are hidden, with care based on standard angiography and clinical information. Both groups receive medical therapy and lifestyle advice based on their diagnosis. The study also includes a registry for patients with obstructive disease who are not randomized. During the study, participants complete symptom questionnaires like the Seattle Angina Questionnaire to assess their angina symptoms and quality of life over at least 12 months. Researchers monitor health status, clinical outcomes, safety, and health economics, with ongoing follow-up planned for up to 10 years. Both patients and their usual care clinicians are blinded to the group allocation, but informed about the diagnosis to guide treatment. The trial aims to enroll 1500 participants across multiple centers in Europe, assessing the feasibility and impact of this stratified medicine approach.

This research aims to evaluate the use of a lower international normalized ratio INR target range of 1.5 to 2.5 in patients with a mechanical bileaflet heart valve placed in the aortic position. The study seeks to determine whether lowering the INR target can reduce bleeding risks without increasing the chance of blood clots or stroke. This is important because patients with mechanical heart valves require lifelong warfarin Coumadin treatment to prevent clot formation, but managing the right balance between clot prevention and bleeding risk remains challenging. Participants will be randomly assigned to one of two groups. One group will receive warfarin therapy adjusted to a lower INR target range of 1.5 to 2.5, while the other group will have warfarin adjusted to a standard INR target range as currently recommended. Both groups will receive warfarin after their mechanical valve implant, but the INR targets for blood thinning will differ. The study includes follow-up over an expected mean of 2 to 3 years to monitor outcomes. During the study, participants will be regularly monitored for blood clot events such as thrombosis or stroke, as well as bleeding episodes, including major and minor bleeding. Researchers will track various outcomes like mortality, different types of stroke, heart attacks, pulmonary embolism, and kidney function over the study period. Time in the therapeutic INR range and occurrences of extreme INR values will also be recorded. Participants will be followed through the study duration, which will help determine the safety and risk balance of using a lower INR target in this patient group.

Researchers are evaluating the long-term safety, tolerability, and effectiveness of orally inhaled seralutinib in adults who have previously completed a seralutinib study for pulmonary arterial hypertension PAH. This open-label extension study continues until seralutinib receives market approval or the study ends, aiming to gather extended information on this treatment in a real-world setting. Participants will receive seralutinib capsules delivered via a generic dry powder inhaler twice daily. The treatment period lasts up to 48 months or until commercial availability of seralutinib. This single-group study allows all participants to receive the investigational drug, focusing on continued evaluation rather than comparison with a placebo or other treatments. During the study, participants will attend scheduled visits for assessments including monitoring of treatment-emergent adverse events, walking distance tests Six-Minute Walk Test, and blood tests measuring NT-proBNP levels at regular intervals up to 48 months. Women of childbearing potential and men with partners of childbearing potential will undergo pregnancy testing and follow contraception guidelines. The research team will closely monitor safety and treatment effects throughout the extended study period.

Researchers are studying how genetic differences affect peoples responses to medicines, which can cause benefits, no effects, or side-effects. This study, called PHOENIX, aims to see if genetic testing before prescribing new medicines can reduce harmful reactions and treatment failures in adult patients admitted to hospital or attending outpatient clinics. It also assesses the cost impact of this genetic-guided care. Participants include adults from various medical specialties who receive medicines with known genetic implications. Participants will be randomly assigned to one of two groups. One group will have their genetic test results analyzed immediately to guide medication decisions, while the other group will have testing done after three months as standard care. All participants provide a cheek swab for DNA testing. The results help doctors decide if any medication changes are needed. Both groups will be monitored for medication side-effects, changes, and quality of life over three months. During the study, participants will complete questionnaires monthly on quality of life, medication adherence, and side-effects. Blood tests may be done around four weeks based on the medication used. Researchers will also collect data on hospital admissions, new prescriptions, and deaths from health records. The main outcome measured is the combination of adverse drug reactions and treatment failures within three months. The study involves follow-up for at least 12 weeks, with safety and health economic evaluations included.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.