Harefield

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are investigating the effects of BudesonideGlycopyrroniumFormoterol Fumarate metered dose inhaler BGF MDI compared with a placebo inhaler on heart and lung function in adults aged 40 to 80 years who have chronic obstructive pulmonary disease COPD and lung hyperinflation. This Phase IV, randomized, double-blind study involves multiple centers and aims to understand how BGF MDI affects cardiac and lung function in this population. Participants will undergo a screening period, followed by receiving placebo inhaler and salbutamol before randomization. The study includes two treatment periods, each lasting 21 days, where participants are randomly assigned to receive either BGF MDI or placebo inhaler first, then switch to the other treatment in the second period. Treatments are given as two inhalations via oral route using a metered dose inhaler. After these periods, a final follow-up phase completes the study. During the trial, participants will be assessed with magnetic resonance imaging MRI to measure changes in left ventricular end diastolic volume indexed by body surface area, along with lung function tests using body plethysmography to evaluate lung volumes. The study monitors participants closely through the treatment and follow-up periods, evaluating changes in heart and lung function to understand the impact of BGF MDI compared to placebo. The total participation includes screening, two 21-day treatment periods, and final follow-up assessments.

Researchers are investigating how cardiac surgery-associated acute kidney injury CSA-AKI develops in people undergoing heart surgeries that use a heart-lung machine. CSA-AKI is a common complication where the kidneys stop working properly, especially in older adults or those with kidney disease and diabetes. The study focuses on understanding the biological processes and biomarkers involved in CSA-AKI during the early hours and days after surgery. Participants in this study will undergo scheduled heart surgeries involving cardiopulmonary bypass as part of their normal medical treatment. The study does not involve any investigational treatments. Instead, blood and urine samples will be collected before and after surgery for biomarker analysis, while patients receive standard care. The study aims to compare these biomarkers between those who develop CSA-AKI within a week after surgery and those who do not. During the study, which lasts up to 2 months per participant, researchers will collect blood and urine samples, review medical records and test reports during hospitalization, and monitor participants overall health. The primary outcome measured is the number of participants developing CSA-AKI within 3 days post-surgery. Secondary outcomes include changes in biomarkers up to 7 days after surgery. This monitoring and data collection will help understand CSA-AKI better and guide future prevention strategies.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are studying Neutral Lipid Storage Disease NLSD and Triglyceride Deposit Cardiomyovasculopathy TGCV, which are rare diseases with limited information about their symptoms and progression. This study aims to gather worldwide data on when these diseases start, background information about affected patients, and their natural disease course. The study also explores factors that may predict disease outcomes and assesses how well specific treatments work. The study involves creating an international registry to collect information from patients diagnosed with NLSD or TGCV. This registry includes patients with Jordans anomaly in certain white blood cells, allowing inclusion of various genetic types of NLSD beyond common gene mutations. The study collects both past medical records and ongoing data from patients. Participants will have their health monitored through various tests and evaluations over up to five years. These include blood tests, muscle and heart assessments, biopsies, imaging scans, exercise tests, and surveys of physical function. The main measure is the time from diagnosis to death from any cause. Secondary measures track many health aspects such as muscle strength, heart and liver function, and neurological symptoms. This long-term observation helps researchers understand the disease and treatment effects better.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction MI specifically ST-segment elevation MI STEMI or non-ST-segment elevation MI NSTEMI who also have multivessel coronary artery disease CAD and have undergone successful treatment of the culprit lesion with Percutaneous Coronary Intervention PCI. The study aims to compare physiology-guided complete revascularization to angiography-guided complete revascularization, focusing on both efficacy and safety outcomes. Participants are randomly assigned to one of two groups. One group receives physiology-guided PCI where the function of non-culprit lesions NCLs is assessed using resting full-cycle ratio RFR or fractional flow reserve FFR, with PCI performed on lesions meeting specific thresholds. The other group undergoes angiography-guided PCI, receiving routine staged PCI on all qualifying NCLs identified before randomization. Both approaches follow local practice standards for PCI. During the study, researchers monitor participants for a minimum of two years to assess the time to first occurrence of major cardiovascular events, including cardiovascular death, new MI, or ischemia-driven revascularization, as well as safety outcomes like significant bleeding, stroke, stent thrombosis, or kidney injury related to contrast use. The trial also includes an observational imaging study using optical coherence tomography in a subset of patients. Follow-up assessments will enable evaluation of both efficacy and safety over the study period.

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.

Researchers are evaluating the investigational drug omecamtiv mecarbil to see if it can lower the risk of serious effects related to heart failure, such as hospitalization, heart transplantation, or death, in patients with symptomatic heart failure and severely reduced ejection fraction. This phase 3 trial aims to assess both the effectiveness and safety of the drug compared to placebo in reducing cardiovascular events including death, heart failure events, left ventricular assist device implantation, cardiac transplantation, and stroke. Participants will be randomly assigned to receive either omecamtiv mecarbil or a placebo. Those in the omecamtiv mecarbil group will take an oral tablet twice daily at a dose based on their blood drug levels 25, 37.5, or 50 mg. The placebo group will receive matching tablets twice daily. The study will continue until at least 850 participants experience a heart failure event or cardiovascular death. An interim analysis will be performed when about 67% of these events have occurred. The total estimated participation duration is up to 3 years. During the trial, participants will be regularly monitored for cardiovascular events, hospitalizations, and other health outcomes. Researchers will measure the time to first cardiovascular death or heart failure event among other secondary outcomes such as stroke and overall survival. Safety will be carefully tracked throughout the study. Participants adherence to the study medication and health status will be assessed at scheduled visits over the course of the study.

This research aims to understand how healthcare professionals collaborate in intensive care units ICUs, focusing on teamwork practices, challenges, and changes since the COVID-19 pandemic. The study observes daily work and explores factors influencing teamwork to support staff resilience and patient safety. It is an observational ethnographic study conducted in multiple ICUs. Participants include healthcare professionals working in selected ICU sites. Researchers will shadow staff during their shifts, observing various interactions such as handovers, ward rounds, and team meetings. Observations occur in 20-minute blocks to reduce burden. In addition, one-on-one interviews with at least 15 healthcare professionals per site will be conducted to gather detailed insights into teamwork experiences. During the study, researchers will collect and analyze fieldnotes and interview transcripts using thematic analysis to identify patterns in teamwork. Observations and interviews will be recorded with consent and anonymized for privacy. The main outcome is to examine changes in teamwork over 12 months after the pandemic. Participants contribute through observation and interviews over four weeks, supporting a comprehensive understanding of ICU teamwork.

Researchers are studying acute coronary syndromes ACS, which include heart attacks and unstable angina, to better understand the causes and improve treatments. This observational study focuses on patients who have experienced these conditions and are undergoing routine angiogram procedures. The goal is to identify new blood markers and clinical signs linked to ACS, especially those related to inflammation and micro-organism activity, to help tailor future treatments more precisely. Participants will provide blood samples during their angiogram procedure, donating about 60 milliliters for research analysis. The study includes patients with different presentations of ACS, such as those with chest pain who receive a cardiac stent and those whose angiograms show normal coronary arteries. The researchers will also gather clinical data from routine procedures like ECG, echocardiograms, and MRI scans. During the study, participants will be followed up at six weeks and six months with questionnaires during their routine clinic visits. One year after the procedure, they will receive a phone call to update information on any events and medication changes. Additional data will be collected from hospital records without contacting participants. Remaining blood samples will be securely stored for future research. The main outcome is to find new biomarkers and clinical parameters associated with ACS over a two to five-year period.