Harefield

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are investigating the effects of a combination inhaler containing Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF MDI) compared to a placebo inhaler on heart and lung function in adults aged 40 to 80 with Chronic Obstructive Pulmonary Disease (COPD) and lung hyperinflation. This Phase IV study is randomized, double-blind, and placebo-controlled, involving multiple centers and a crossover design to ensure thorough evaluation of the treatment's impact. Participants will first go through a screening period where they receive placebo inhaler and salbutamol before randomization. The study includes two treatment periods of 21 days each, during which participants are randomly assigned to receive either the BGF metered dose inhaler or a matching placebo and then switch treatments in the second period. Both treatments are delivered as two inhalations via oral route using a metered dose inhaler. After these treatment periods, there is a final follow-up phase. During the study, researchers will closely monitor changes in heart function by measuring the left ventricular end diastolic volume indexed by body surface area using magnetic resonance imaging (MRI) up to three weeks. Lung function and other assessments will also be performed throughout the study. Participants will undergo various evaluations including lung function tests, blood counts for eosinophils, and safety monitoring to assess the treatment effects and ensure participant well-being during the trial.

Researchers are investigating how cardiac surgery-associated acute kidney injury (CSA-AKI) develops in people undergoing heart surgeries with the use of a heart-lung machine. CSA-AKI is a common complication where the kidneys stop working properly after heart surgery. Factors increasing the risk include older age, kidney disease, diabetes, and longer use of the heart-lung machine during surgery. The study focuses on understanding the mechanisms of CSA-AKI by examining biomarkers in blood and urine, especially in the early hours and days after surgery. Participants will not receive any experimental treatments. Instead, they will undergo heart surgery and related medical care as planned by their doctors. The study involves collecting blood and urine samples before and after surgery and reviewing medical records during hospitalization. No investigational interventions will be given; the research only adds sample collection and data review to standard care. Each participant will be involved for up to two months. During this time, the study team will monitor their overall health, collect biological samples, and assess medical data to compare those who develop CSA-AKI within a week after surgery to those who do not. The main measurement is the number of participants who develop CSA-AKI up to three days post-surgery. This research aims to improve understanding of CSA-AKI and help develop future treatments to prevent it.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating whether adult patients who have undergone cardiac surgery can safely and effectively collect their own wound swabs at home. This observational feasibility study focuses on patients aged 18 and over with a closed central chest wound following surgery. The study aims to determine if self-swabbing can produce good quality samples for microbiological testing, if the process is safe and acceptable, and whether it could be a cost-effective way to monitor for surgical wound infections. Participants will receive a specially designed self-swabbing instruction pack created with input from patients and clinical experts. They will perform the self-swabbing of their surgical wound while being observed remotely by a research practitioner via Microsoft Teams video call to assess how well they follow the instructions. Completed swabs are then sent to the hospital laboratory for analysis. Participants will also take part in a brief interview to share their experiences and feedback about the swabbing process. During the study, researchers will monitor how many participants can successfully complete self-swabbing, how acceptable the process is based on participant ratings, adherence to the swabbing protocol, and any adverse events related to the swabbing. The study is conducted at two UK hospitals, and participants will be followed from 7 to 11 months after surgery to collect these outcomes.

Researchers are studying Neutral Lipid Storage Disease (NLSD) and Triglyceride Deposit Cardiovasculopathy (TGCV), rare diseases with limited patient information worldwide. The study aims to better understand the onset, patient backgrounds, natural progression, prognostic factors, and effectiveness of disease-specific treatments. Due to the rarity and limited cases in each country, this international collaboration collects comprehensive data through a global registry. This effort involves both prospective registration of newly diagnosed patients and retrospective collection of past medical records. Patients with Jordans' anomaly in peripheral polymorphonuclear leukocytes are also included to capture cases caused by different genetic mutations beyond the known genes ATGL and CGI-58. Participants' data will be recorded to monitor their health outcomes over time, primarily focusing on the period from diagnosis to death from any cause within five years. This registry helps researchers track disease progression and treatment responses to improve understanding and care for those affected by NLSD and TGCV.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction (MI), including both ST-segment elevation MI (STEMI) and non-ST-segment elevation MI (NSTEMI), who also have multivessel coronary artery disease (CAD). The trial compares physiology-guided revascularization, which uses specific measurements to decide treatment, with angiography-guided revascularization, which relies on imaging. The study aims to determine if the physiology-guided approach is not worse than the angiography-guided method in preventing cardiovascular death, new MI, or ischemia-driven revascularization, and whether it is better at reducing safety issues like bleeding, stroke, or kidney injury. Participants undergo procedures to treat non-culprit lesions (NCLs) using either physiology guidance or angiography guidance. In the physiology-guided group, percutaneous coronary intervention (PCI) is performed on lesions with resting full-cycle ratio (RFR) of 0.89 or less or fractional flow reserve (FFR) of 0.80 or less, according to local practice. The angiography-guided group receives PCI based on imaging assessments following local practice. The study includes an observational imaging sub-study using optical coherence tomography (OCT) for a subset of patients. Participants are involved for a minimum of two years, during which researchers monitor the time to first cardiovascular events such as death, new MI, or additional revascularization, along with safety events like bleeding or stroke. The study includes regular evaluations and follow-up to assess these outcomes, ensuring comprehensive safety and efficacy data collection in this patient population.

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.

Researchers are evaluating the effectiveness and safety of the investigational drug omecamtiv mecarbil in patients with symptomatic heart failure and severely reduced ejection fraction. This study aims to see if the drug can lower the risk of serious heart-related events, such as cardiovascular death, heart failure events, need for heart device implantation, heart transplantation, or stroke. The study is a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial involving adults aged 18 to 85 years. Participants will be randomly assigned to receive either omecamtiv mecarbil or a placebo, both given as oral tablets. The study is event-driven and will continue until at least 850 participants have experienced either a heart failure event or cardiovascular death. An interim analysis will be done after about 570 such events have occurred. The estimated participation period for each patient is up to 3 years. During the study, participants will be monitored for the time until the first occurrence of cardiovascular death or heart failure event. Researchers will collect various health data and monitor safety throughout the study. The study includes regular assessments to track heart function and adverse events, with follow-up until the study concludes when the required number of events is reached.

Researchers are studying acute coronary syndromes, including heart attacks and unstable angina, to better understand the causes and improve treatment. The study focuses on patients undergoing coronary angiography after experiencing these heart conditions. It aims to identify new biomarkers and clinical signs linked to these syndromes, with particular attention to inflammation and microorganism activity. This research hopes to provide detailed information about heart attack patients through comprehensive clinical data and blood samples. Participants will be asked to donate 60 milliliters of blood during their routine angiogram procedure. The study collects data from standard tests such as ECG, echocardiograms, and MRI scans. After the initial procedure, researchers will follow up at 6 weeks and 6 months with questionnaires during routine appointments. At one year post-procedure, participants will be contacted by phone to update health events and medication use. Additional data will also be collected from hospital records without further participant contact. Remaining blood samples will be securely stored for future analysis. Throughout the study, participants will be monitored for up to five years to track novel biomarkers and clinical factors associated with acute coronary syndromes. Researchers will gather ongoing clinical data, imaging results, and questionnaire responses to better characterize patient risk and outcomes. This long-term follow-up includes safety monitoring and additional data collection from hospital records, supporting advances in personalized treatment strategies.