Harefield

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3 randomized, double-blind, placebo-controlled study to assess its effect on reducing major adverse cardiovascular events in patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study compares AZD0780 with a placebo and is event-driven, focusing on time to first cardiovascular events over approximately 54 months. Participants will be randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study treatment continues from randomization until the primary analysis censoring date, followed by a study closure visit which marks the final visit for each participant. Background lipid-lowering therapy is maintained and expected to achieve significant LDL cholesterol reduction. The study design includes parallel treatment groups with quadruple masking to ensure unbiased results. During the study, participants attend regular visits for monitoring and assessments over a period that can last up to about 54 months. Researchers will measure the time to first major cardiovascular events including heart attack, stroke, urgent coronary revascularization, cardiovascular death, and other related outcomes. Safety and efficacy are carefully monitored through clinical evaluations, laboratory tests, and patient follow-up until study completion.

Researchers are evaluating the effect of BudesonideGlycopyrroniumFormoterol Fumarate Metered Dose Inhaler BGF MDI compared with a placebo inhaler on heart and lung function in people diagnosed with Chronic Obstructive Pulmonary Disease COPD and lung hyperinflation. This Phase IV study is randomized, double-blind, and placebo-controlled, aiming to better understand how BGF MDI impacts these functions in affected patients. Participants will undergo screening and receive a placebo inhaler and salbutamol before randomization. The study includes two treatment periods lasting 21 days each, where participants receive either BGF MDI or placebo inhaler in the first period and then switch to the other in the second period. The inhalers are administered as two inhalations by mouth during these treatment phases. Following these periods, there is a final follow-up phase. Throughout the study, participants will have their heart and lung function monitored using magnetic resonance imaging MRI to measure changes in left ventricular end diastolic volume and body plethysmography to assess lung volumes. Researchers will also track lung function before and after treatments, along with safety assessments. The entire participation may last several weeks, including screening, treatment, and follow-up visits.

Researchers are investigating cardiac surgery-associated acute kidney injury CSA-AKI, a frequent complication where the kidneys malfunction after heart surgeries involving a heart-lung machine. The study focuses on understanding how CSA-AKI develops, especially in the early hours and days post-surgery, by examining certain biological markers biomarkers that may signal this condition. The aim is to better understand CSA-AKI mechanisms and identify potential targets for prevention or treatment. Participants scheduled for heart surgeries using cardiopulmonary bypass will be observed without receiving any experimental treatments. Blood and urine samples will be collected before and after surgery for biomarker analysis. The study involves participants receiving their usual medical care during and after surgery, with no investigational interventions administered. Throughout the study, which lasts up to two months per participant, researchers will collect blood and urine samples, review medical records and test results from hospitalization, and monitor overall health. The primary outcome is the number of participants developing CSA-AKI within three days after surgery. Secondary outcomes include changes and levels of specific biomarkers up to seven days post-surgery, helping to understand the relationship between these markers and CSA-AKI occurrence.

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 conducting a Phase III international study to evaluate the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients with chronic heart failure HF and impaired kidney function who have recently experienced a heart failure event. The study aims to assess the impact of these treatments on cardiovascular death and heart failure events, including hospitalizations and other HF-related episodes. Participants are randomly assigned to one of three groups one receiving balcinrenonedapagliflozin 15 mg10 mg capsule plus placebo another receiving balcinrenonedapagliflozin 40 mg10 mg capsule plus placebo and a third group receiving dapagliflozin 10 mg tablet plus placebo capsule. All treatments are given once daily orally, alongside standard care for heart failure and kidney impairment. The study is conducted across approximately 700 sites in about 40 countries. During the trial, participants will be monitored over approximately 36 months for cardiovascular death, heart failure hospitalizations, and heart failure events without hospitalization. Assessments include heart failure symptom scores measured at 24 weeks post-randomization. Researchers will also track total occurrences of cardiovascular and heart failure events, as well as overall mortality. This long-term follow-up aims to evaluate treatment effects on these important health outcomes.

Researchers are evaluating the investigational drug omecamtiv mecarbil to see if it can reduce the risk of serious effects related to heart failure, such as hospitalization, heart transplantation, or death, in patients with symptomatic heart failure with severely reduced ejection fraction HFrEF. This Phase 3 trial compares the safety and effectiveness of omecamtiv mecarbil against a placebo in patients with this condition. Participants will be randomly assigned to receive either omecamtiv mecarbil or a placebo. Those in the omecamtiv mecarbil group will take oral tablets twice daily with doses adjusted based on drug levels in their blood 25, 37.5, or 50 mg. The treatment continues until at least 850 participants experience a heart failure event or cardiovascular death. This is a double-blind study, meaning neither participants nor study staff know who receives the drug or placebo. During the study, participants will be monitored up to about 3 years. Researchers will track occurrences of cardiovascular death, heart failure events, device implantations, heart transplants, and strokes. Participants will have regular visits and assessments to monitor their health and study outcomes. Safety and efficacy data will be collected until the study concludes when the required number of events has occurred.

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.