Clydebank

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

Researchers are evaluating APL-9796 in adults with pulmonary hypertension (PH) to understand its safety, tolerability, and potential effectiveness. This phase 2, open-label trial involves patients with WHO Group 1 Pulmonary Arterial Hypertension (PAH) and optionally, those with WHO Group 3 PH associated with interstitial lung disease (PH-ILD). An important goal is to assess whether the body develops antibodies against APL-9796 during treatment. The study is divided into two parts: Part A will include up to 36 adults with WHO Group 1 PAH, organized into three cohorts receiving multiple subcutaneous injections of APL-9796. Part B is optional and may include up to 12 adults with WHO Group 3 PH-ILD if approved by the Safety Review Committee. The trial will explore dose escalation and the effects of repeated dosing. Participants will be closely monitored throughout the study, which lasts approximately two years. Researchers will track treatment-emergent adverse events to evaluate safety and tolerability. The trial requires participants to have a CardioMEMS PA Sensor implanted and will use right heart catheterization data for diagnosis confirmation. Ongoing assessments will measure health status and any immune response to the drug.

Researchers are evaluating the effects of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing coronary artery bypass grafting (CABG). This international, multi-center randomized trial named ROMA:Women aims to determine whether MAG improves major heart and brain-related events and quality of life compared to SAG. The study includes 2,300 women to examine outcomes like death, stroke, heart attacks, repeat surgeries, and hospital stays, along with quality of life and mental and physical health symptoms in a subgroup of 500 participants. Important patient subgroups such as age, diabetes status, race, surgical techniques, and type of arterial grafts will also be analyzed. Participants will be randomly assigned to receive either single arterial grafting, where the left internal thoracic artery is connected to the heart's left anterior descending artery along with venous grafts, or multiple arterial grafting, where an additional arterial graft such as the right internal thoracic artery or radial artery is used for other coronary branches, plus other grafts as needed. The trial leverages existing infrastructure and continues enrollment with additional sites to reach its target sample size. Both treatment arms follow the same randomization, interventions, and follow-up protocols as the parent ROMA trial. During the study, researchers will monitor participants for at least 2.5 years after surgery to track major cardiac and cerebrovascular events and assess disease-specific and generic quality of life measures using questionnaires such as the Seattle Angina Questionnaire and PROMIS-29. The trial will collect data through clinical assessments and questionnaires to evaluate health outcomes and symptom changes. Safety and effectiveness will be closely followed to understand the impact of the two grafting methods in women undergoing CABG.

Heart attack, specifically acute ST-segment elevation myocardial infarction (STEMI), is a leading cause of heart failure and death due to damage from lack of blood and oxygen to the heart muscle. Despite research, few new treatments have been shown to prevent heart failure after a heart attack. This study investigates the use of supersaturated oxygen therapy given through the wrist after standard treatment to increase blood oxygen levels and potentially improve outcomes. It is an academic trial focusing on patients who have undergone primary percutaneous coronary intervention (PCI) within 6 hours of symptom onset. The study compares two groups: one receiving supersaturated oxygen therapy via radial artery access immediately after PCI for one hour, and a control group receiving a sham procedure mimicking the therapy without oxygen infusion. The oxygenated blood is delivered using a special catheter through the wrist, while the control group undergoes a similar process without the active treatment. Both groups receive standard care, and the study is randomized and blinded so that patients and clinical staff do not know the treatment assigned. Participants undergo blood samples, coronary angiography, coronary physiology assessments, heart MRI scans at 2-5 days and again at 3 months, and health questionnaires. Safety, feasibility, and effects on heart damage markers, including N-terminal pro-B-type natriuretic peptide at 3 months, are monitored. Follow-up includes in-person visits up to one year and potential longer-term electronic health record checks. The study aims to provide preliminary information to determine if a larger trial is needed.

Researchers are studying patients with known or suspected angina who do not have obstructive coronary artery disease to see if a special diagnostic test can help guide personalized treatment. This condition includes ischaemic heart disease, microvascular angina, and vasospastic angina. The trial builds on earlier research suggesting that tailoring treatment based on coronary vascular function tests may improve symptoms and quality of life. This large, multicentre, blinded, randomized study aims to confirm these findings and assess effects on health and wellbeing over a longer period. Participants undergo invasive coronary angiography along with an adjunctive interventional diagnostic procedure (IDP) that measures coronary vascular function using a guidewire technique. Patients with no significant artery blockage are randomized into two groups: one where IDP results are disclosed to guide treatment decisions, and a control group with concealed results receiving standard care. Those with abnormal vascular function in the intervention group may have repeated assessments to tailor medications, such as calcium channel blockers. Patients with obstructive artery disease or other exclusions may join a registry for follow-up and assessment. Throughout the study, participants complete questionnaires about angina symptoms, quality of life, activity levels, treatment satisfaction, and pain. Researchers monitor clinical outcomes for at least 12 months, including major cardiovascular events. The study also evaluates the safety and usefulness of the diagnostic procedure in multiple hospitals across Europe. Blood samples are collected to explore disease mechanisms. Participants and their doctors remain blinded to group assignments, but diagnoses are shared to help guide care following current guidelines.

Researchers are evaluating the use of a lower INR target range (1.5 to 2.5) in patients who have a mechanical bileaflet heart valve in the aortic position. The study aims to determine whether this lower INR target can reduce the risk of bleeding without increasing the risk of blood clot formation or stroke. This is important because patients with mechanical heart valves need lifelong warfarin treatment, and finding the right INR balance could lessen bleeding complications. Participants will continue warfarin therapy after their mechanical valve replacement, but with different INR target ranges depending on their study group. The study compares the standard higher INR targets to the lower 1.5 to 2.5 range to assess safety and effectiveness. This is a Phase 3 clinical trial focusing on patients who had their bileaflet mechanical heart valve implanted at least three months prior. During the study, participants will be monitored for thrombosis or thromboembolism and major bleeding events over a period expected to last 2 to 3 years. Researchers will regularly measure INR levels to guide warfarin dosing and track outcomes related to bleeding and clotting. The results are intended to help doctors better manage warfarin dosing to reduce bleeding risks while preventing clots in this patient group.

Researchers are evaluating two different treatments for adults aged 60 years and older with severe primary degenerative mitral regurgitation (MR), a condition affecting the heart's mitral valve. This multicenter, open-label, randomized trial compares mitral valve transcatheter edge-to-edge repair (TEER) with traditional surgical repair. The study aims to assess the long-term effectiveness, safety, and patient-centered outcomes such as quality of life and functional status. It will take place in multiple countries including the U.S., Canada, Germany, Spain, and the United Kingdom, and includes devices legally approved in each country. The trial is conducted under an Investigational Device Exemption (IDE) due to regulatory considerations in the U.S.

Researchers are studying how genetic differences affect people's responses to medicines, aiming to reduce side effects and treatment failures. This pilot trial, called PHOENIX, focuses on adults admitted to hospital or attending specialist clinics who need a new prescription for drugs known to have pharmacogenomic implications. The study will provide early information on whether using genetic testing to guide medication choices can improve patient outcomes and health economics in acute care settings. Participants will be randomly assigned to two groups: one group will have pharmacogenomic testing performed immediately using a cheek swab, while the other group's testing will be delayed until three months later. The test analyzes key genes affecting drug response, and results are sent to the treating clinician with recommendations on medication adjustments if needed. This approach allows doctors to consider genetic factors when prescribing medications. The trial limits recruitment for commonly prescribed drugs to maintain balance. During the study, participants will complete monthly questionnaires on quality of life, medication adherence, and side effects for three months. Blood tests for safety monitoring will be done about four weeks after starting the medication, depending on the drug used. Researchers will collect data on new prescriptions, hospital admissions, and deaths through health records linked anonymously. The primary outcome is a combination of adverse drug reactions and treatment failures assessed at three months.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.