Cardiac Arrhythmia

Researchers are evaluating whether the Breathlessness diagnostics in a Box (BiaB) tool can shorten the time to diagnosis for patients experiencing breathlessness compared to usual care. This prospective, interventional study uses a stepped-wedge cluster design in general practice settings across the Netherlands, Spain, and Portugal. The main goal is to see if BiaB speeds up diagnosis, with secondary aims to identify more cases of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), and to assess the tool's usability and efficiency. The study involves 45 general practice sites that start with a usual care period and sequentially transition to using the BiaB tool. Patients receive care as part of their regular visits, either through standard diagnostic procedures or with support from BiaB. No additional treatments are mandated by the study. Each site participates for 40 weeks, and data are gathered from routine clinical visits, electronic medical records, and questionnaires completed by patients and healthcare professionals. Participants attend a single study visit and may complete up to four quarterly questionnaires over a follow-up period lasting up to one year. Researchers measure the time from first presentation of breathlessness to diagnosis, the number of new COPD and CVD diagnoses, and the usability of the BiaB tool. Data are collected continuously during the usual care and intervention phases, allowing comparison of outcomes between these periods.

Spinal anesthesia-induced hypotension is a common and significant complication affecting up to 50-80% of pregnant women undergoing elective cesarean section. This trial evaluates whether a brief 5-minute mindfulness-based breathing exercise given just before spinal anesthesia can influence blood pressure changes during surgery. The study compares this breathing technique to standard care in pregnant women aged 18 to 45 years scheduled for elective cesarean delivery. Participants will be randomly assigned to either perform the mindfulness-based breathing exercise or receive standard preoperative care. The breathing exercise involves slow diaphragmatic breathing at about six breaths per minute, guided by a trained anesthesiologist or nurse, with mindful repetition of the phrase "My body is relaxing as I exhale." Both groups receive spinal anesthesia with specific medications, and careful monitoring of heart rate and blood pressure is performed. During the study, participants will be closely observed for changes in systolic blood pressure and heart rate within 10 minutes after spinal anesthesia. Anxiety levels, incidence of early hypotension, and medication use to support blood pressure will also be measured. The trial includes standard monitoring such as ECG and oxygen saturation, with safety and response data collected throughout the procedure. Participants' involvement includes a short breathing exercise or equivalent wait time before anesthesia, with follow-up assessments during surgery.

Researchers are evaluating two different pacing methods for patients with slow heart rates in this multi-center trial. The study compares the standard right ventricular pacing with a newer physiological pacing approach, which includes His bundle pacing or left bundle pacing. This trial aims to better understand the effects of these pacing methods on heart function and patient outcomes over time, including a sub-study focused on heart muscle changes related to pacing. Participants will receive a pacemaker implanted at a participating center and be randomly assigned to either right ventricular pacing or physiological pacing. For physiological pacing, if His or left bundle pacing is not successful, biventricular pacing will be used instead. The trial includes an optional echocardiographic sub-study for some patients to assess heart changes over 24 months. Participants will be followed for up to 78 months, with assessments at baseline and every six months. Researchers will measure outcomes such as survival, heart failure events, quality of life questionnaires, symptoms, device-related safety events, and heart rhythm data collected from the pacemakers. The sub-study will use echocardiograms to evaluate changes in heart volume and pumping efficiency. This comprehensive follow-up aims to capture both clinical effects and mechanistic insights of the pacing methods.

Heart failure is a leading cause of hospital admission in Ghana, accounting for about 88.3% of cardiac cases. Despite advances in treatment guidelines, many patients face repeated hospital readmissions, which increase the risk of death. This research aims to evaluate whether extensive counseling after discharge combined with regular phone follow-ups can reduce the rate of hospital readmissions within 30 and 90 days for heart failure patients at a major hospital in Ghana. The study compares two groups of heart failure patients: one receiving usual care, which includes counseling by their attending physicians and standard outpatient reviews, and another receiving additional extensive post-discharge counseling from a study doctor, pharmacist, or trained nurse, along with weekly phone follow-ups for the first 30 days and then every four weeks up to day 90. This approach aims to provide more support after hospital discharge to help reduce readmissions. Participants will be monitored over a 90-day period after discharge, with regular assessments through phone calls and outpatient visits. Researchers will track hospital readmission rates at both 30 and 90 days as the primary outcome. The study involves collecting information on patient adherence to treatment and follow-up care, aiming to better understand how enhanced support can impact heart failure management and reduce repeat hospitalizations.

Researchers are exploring the link between myocardial fibrosis and outcomes in patients with Atrial Fibrillation (AF) after catheter ablation. The study focuses on using Cardiac CT to measure left ventricular extracellular volume (ECV) as a sign of fibrosis. It aims to see if higher ECV levels are connected to greater risks of AF returning, hospitalizations, and poor heart function recovery. This could help guide AF treatment decisions. Participants who are referred for catheter ablation will undergo an extra CT scan to measure ECV before the procedure. This is done during the standard pre-ablation cardiac CT that maps heart anatomy. The study uses a 320-detector CT to quantify ECV, a widely available and high-resolution method compared to MRI. The research assesses if ECV expansion relates to AF burden. During the study, outcomes such as AF recurrence and cardiovascular-related emergency visits or hospitalizations will be tracked for up to 90 days after the procedure. Heart function changes will be measured by ejection fraction, and quality of life will be assessed using the Atrial Fibrillation Effect on Quality-of-Life questionnaire. Participants will be monitored carefully during this period to evaluate these clinical outcomes.

The trial investigates the use of 3D transesophageal echocardiography (TEE) to analyze the right ventricle's function in patients undergoing left ventricular assist device (LVAD) implantation. LVADs help support the left ventricle in patients with severe heart failure. Because right ventricular failure after LVAD implantation is common and linked to complications, this study aims to better predict which patients are at higher risk by using advanced 3D imaging methods. Participants receive one of several types of left-sided LVADs, including HeartMate III, HeartWare HVAD, or Levitronix CentriMag devices. During the LVAD implantation procedure, 3D TEE images of the right ventricle are taken and analyzed. The study focuses on gathering detailed heart function data and does not involve additional treatments or interventions beyond standard device implantation. During the study, researchers collect various heart function measurements within 24 hours after implantation, such as ventricular strain, volumes, ejection fractions, and tricuspid annular plane systolic excursion. Secondary outcomes include monitoring clinical data and lab tests over 14 days post-implantation. Participants are observed for right ventricular function and related support needs. The study started in March 2022 and will continue through January 2027, involving no experimental treatments beyond imaging and data collection.

Researchers are investigating myocardial fibrosis in patients with heart failure, focusing on those with non-ischemic dilated cardiomyopathy (HFrEF phenotype) and hypertrophic cardiomyopathy (a subtype of HFpEF). The study explores the use of gallium-68-labeled fibroblast activation protein inhibitor positron emission tomography/computed tomography (68Ga-FAPI PET/CT) compared to the current standard, cardiac magnetic resonance imaging (CMR), to better detect and monitor fibrosis activity. This observational pilot study aims to improve non-invasive methods for assessing fibrogenesis and treatment effects. Participants will undergo 68Ga-FAPI PET/CT scans to evaluate myocardial fibrosis. The study includes patients with preserved or reduced left ventricular ejection fraction meeting specific imaging and diagnostic criteria. Recent echocardiograms, cardiac magnetic resonance imaging, and normal coronary angiogram or CT coronary angiography are required within specified timelines. The study is single-center and prospective, focusing on developing new assessment methodologies for future anti-fibrotic therapies. During the study, participants will be monitored through imaging assessments at baseline and after two years to measure 68Ga-FAPI uptake. Researchers will also correlate imaging findings with serum cardiac biomarkers and cardiovascular events. The study requires participants to have stable conditions without recent hospitalizations for heart failure and includes safety monitoring concerning kidney function and tolerance to procedures. The total participation duration may span over two years with repeated evaluations.

Researchers are studying how blood flow to muscles is controlled and how this changes with age and certain diseases such as chronic obstructive pulmonary disease (COPD), sepsis, pulmonary hypertension, and cardiovascular disease. The study focuses on four key pathways that affect blood vessel constriction and dilation: Angiotensin-II, Endothelin-1, Nitric Oxide, and oxidative stress. The goal is to better understand how these pathways contribute to reduced blood flow during exercise and whether these changes can be improved. Participants will receive various treatments including exercise tests and drugs that affect blood vessel function, such as Nitric Oxide blockers, antioxidants, receptor antagonists, and other vasoactive agents. These treatments will be given through catheter placements for measurements and infusions. Different groups include healthy young adults, older adults, and patients with conditions like COPD, pulmonary arterial hypertension, heart failure, and hypertension. The study will also evaluate effects before and after exercise training. During the study, participants will undergo tests such as maximum exercise capacity, measurements of blood flow, blood pressure, muscle metabolism, and muscle fatigue using advanced imaging techniques like Nuclear Magnetic Resonance (NMR). Researchers will monitor changes in limb blood flow and other outcomes at baseline and one hour after treatments. The study aims to provide detailed insight into how vascular function changes with age and disease and how it responds to various interventions over time.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-5765 in healthy adults aged 18 to 65 years. This phase I randomized, double-blind study also explores how food affects HRS-5765's pharmacokinetics and its impact on certain metabolic enzymes. The trial is sponsored by Chengdu Suncadia Medicine Co., Ltd. and focuses on healthy volunteers without significant health issues. Participants will be randomly assigned to receive either a specified dose of HRS-5765 tablet or a matching placebo. The study includes single and multiple oral dosing periods, with dose escalation across cohorts. The trial includes a food effect period to assess medication behavior with meals. Treatments are given orally, and participants remain blinded to their assigned group throughout the trial. During the study, participants are closely monitored for adverse events and serious adverse events from day 1 through day 21, depending on the dosing period. Researchers will measure drug levels in the blood, including maximum concentration, time to reach this level, overall exposure, and clearance from the body over 18 days. Safety assessments, laboratory tests, physical exams, and adherence to diet and contraception requirements are also conducted. The total study duration varies by participant depending on dosing and follow-up periods.

Researchers are evaluating the use of sodium zirconium cyclosilicate (SZC) to help optimize renin-angiotensin aldosterone system inhibitor (RAASi) therapies in elderly patients aged 70 and older who have heart failure and chronic kidney disease. Many patients with these conditions do not receive recommended RAASi doses because of elevated potassium levels, which can be dangerous. This study aims to see if adding SZC allows safer and more effective use of RAASi medications by managing potassium levels. This is a randomized, open-label clinical trial where eligible participants who have been hospitalized for heart failure worsening and have mild or at-risk hyperkalemia will be assigned to one of two groups. One group receives SZC along with standard RAASi treatment, while the other receives RAASi treatment alone without potassium binders. The treatment period lasts three months, during which RAASi doses are adjusted following European Society of Cardiology guidelines. Participants will be monitored from screening through three months of treatment to measure how many can increase their RAASi doses by at least 25%. Evaluations include clinical assessments, potassium level monitoring, and adherence to therapy. The study will also track secondary outcomes related to higher dose increases. Safety and treatment effects will be observed throughout the trial, which is expected to provide important insights for managing these conditions in elderly patients.