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 tools 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, called bradycardia. This study compares the common right ventricular pacing approach with a newer physiological pacing method that includes His bundle and left bundle area pacing. The trial aims to better understand how these pacing techniques affect patient outcomes, including mortality and heart failure morbidity, in a large group of 2600 patients. Participants will receive a pacemaker implant and be randomly assigned to either right ventricular pacing or physiological pacing. The physiological pacing may involve His bundle pacing or left bundle pacing, but if these are not successful, biventricular pacing will be used. A subgroup of 500 participants will take part in an optional echocardiographic sub-study to assess heart function changes over a 24-month period. Throughout the study, patients will be assessed at baseline and every six months after randomization, with follow-up lasting up to 78 months. Researchers will monitor outcomes such as mortality, heart failure events, device-related safety issues, patient quality of life, symptoms, and pacemaker-derived data like arrhythmias and activity levels. The echocardiographic sub-study will measure specific heart function changes to understand pacing-induced cardiomyopathy. Participants involvement includes implantation, regular follow-up visits, questionnaires, and optional imaging assessments.

Researchers are evaluating the radiopharmaceutical 18F-meta-fluorobenzylguanidine 18F-mFBG as a new imaging agent to measure myocardial sympathetic innervation in stable patients with heart failure due to ischemic cardiomyopathy. This Phase 2 study focuses on adults who have a left ventricular ejection fraction of 35% or less and have implantable cardioverter-defibrillators ICDs. The study aims to compare 18F-mFBG uptake with historical imaging agents and assess differences in sympathetic innervation related to past ICD activations. Participants will receive two PET radiopharmaceuticals intravenously 18F-mFBG to assess sympathetic innervation and Rubidium-82 to assess myocardial blood flow. The study groups consist of patients who have experienced ICD activation within the past 12 months and those who have not. Both imaging agents will be used to examine cardiac regions for abnormalities and to quantify myocardial uptake patterns during the study. During the trial, participants will undergo PET imaging and safety monitoring for 24 hours after the administration of these agents. Researchers will collect imaging data, evaluate heart function, and monitor for any adverse or serious adverse events. The study will assess how well 18F-mFBG works compared to previous imaging methods and gather safety information over the course of participation.

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 ventricles 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 tomographycomputed tomography 68Ga-FAPI PETCT 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 PETCT 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-5765s 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.