Clinical Research Directory

Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways

Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm monitoring. The study evaluates a clinician-facing, AI-enabled decision-support system that analyzes data from the Cor XT and Cor MDx wearable ECG devices and organizes patient-specific findings into an integrated Cor360 report for review by qualified clinicians. Rather than focusing only on detection of arrhythmias, Cor360 evaluates multiple dimensions of cardiovascular physiology and disease simultaneously. The active Cor360 indication panel may include more than 150 reportable findings or sub-findings organized across six clinically oriented pathways: Structural, Functional, Conductance, Hemodynamic, Neurohormonal/Autonomic, and Atrial Fibrillation/Ventricular Arrhythmia/Sudden Cardiac Death. Depending on the ECG data available for an individual participant, Cor360 may characterize findings and risk markers related to left ventricular hypertrophy and atrial enlargement; heart-failure phenotype and ejection-fraction-related abnormalities; conduction delay and heart block; repolarization and ischemia-related abnormalities; atrial fibrillation and atrial substrate; ventricular ectopy, nonsustained ventricular tachycardia and electrical-instability markers; syncope mechanisms; and selected ECG-derived hemodynamic and structural/functional surrogates. The platform may also evaluate autonomic regulation and heart-rate variability, cardiopulmonary coupling, sleep-disordered breathing and obstructive sleep apnea screening indicators, electrolyte-related ECG abnormalities, and other clinically relevant physiologic patterns. Cor360 is designed to move from isolated ECG findings toward multidimensional cardiac phenotyping and multi-pathway risk assessment. Individual findings may be combined into clinically meaningful phenotypes and risk profiles, such as atrial-fibrillation-prone substrate, heart-failure-related autonomic or repolarization profiles, ventricular electrical-instability patterns, ischemia-related risk signals, or sleep-disordered-breathing-related cardiovascular burden. Where repeated ECG studies are available, Cor360 may also assess changes in cardiac phenotype, physiologic state, and risk trajectory over time. Reports are individualized rather than identical across participants. Only indications supported by the participant's available data, signal quality, monitoring duration, and applicable analysis criteria are presented. Longer-duration recordings may support deeper assessment of autonomic function, sleep-related physiology, intermittent abnormalities, and longitudinal risk patterns. Cor360 also evaluates whether an extended wearable ECG record can support cross-domain clinical synthesis rather than requiring each physiologic signal to be interpreted in isolation. When appropriate, reports may link detected phenotypes and risk markers to guideline-informed care-pathway considerations while identifying uncertainty, data-quality limitations, and findings that are not reportable because monitoring-duration or signal criteria are not met. The primary objective of the study is to determine whether clinicians judge Cor360 reports to provide clinically actionable cardiac phenotyping or risk-assessment information. The study will also evaluate whether reviewing a Cor360 report changes, refines, or confirms a clinician's assessment or intended care pathway, and how Cor360 findings agree with available clinical reference information, standard-of-care testing, or independent expert review. The study includes adults 18 years of age or older with completed or planned Cor XT or Cor MDx wearable ECG monitoring. It includes retrospective and prospective single-study assessments, longitudinal repeated-study assessments, combined retrospective/prospective analyses, and selected limited-duration streaming or patient-activated event assessments. The protocol spans real-world acquisition settings, including home, clinic, ambulatory care, emergency department/triage, ambulance or transport, hospital-based, and hybrid clinic-to-home workflows. Where suitable reference information is available, Cor360 findings may be compared with 12-lead ECG interpretation, Holter or ambulatory ECG findings, echocardiography, other imaging, laboratory results, sleep testing, clinical diagnosis, or blinded expert-panel review. Cor360 is being evaluated as a clinician-facing decision aid and not as an autonomous diagnostic system. Its outputs are intended to augment clinical interpretation and support consideration of relevant care pathways, including rhythm management, heart-failure evaluation, ischemia assessment, conduction or pacing evaluation, and sleep-apnea work-up. The clinician remains responsible for diagnosis, treatment, testing, referral, and patient management.

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.

Detecting the Undetected: Heart Failure Screening at the Lymphoedema Point of Care

Heart failure affects more people than the four most common cancers combined. When identified early, management is more straightforward, preventing complications, hospitalisations, and fatalities. Breathlessness and fatigue are cardinal symptoms of heart failure that can present in a number of conditions. As a result, leg swelling, the third cardinal symptom, is the first noted in many people. The presence of leg swelling leads to patients being seen in lymphoedema clinics before the need for cardiology investigation has been identified. Lymphoedema is the presence of chronic oedema as a result of congenital abnormalities, inflammation, infection, trauma, or cancer and its treatments. The vast majority of lymphoedema patients have swelling in their legs. A recent study has shown that 9.4% lymphoedema patients need to be investigated for heart failure. At present, the need for investigation is identified by performing a laboratory blood test, which takes time to arrange and complete. An alternate point of care test can provide a result in 12-minutes at the lymphoedema appointment, and enable appropriate action to be taken. This can reduce the demands on primary care and shorten the chain of events to a specialist assessment, as well as reducing inappropriate referrals. This research, funded by NHS Wales Performance and Improvement, will perform a point of care test to screen for possible heart failure in lymphoedema clinics and establish the clinical utility by exploring the experiences of patients and staff involved and determining the health economic benefits. A supplementary aim is to compare the point of care test to the currently used laboratory test in a subsample to promote confidence in the test and support efforts to spread and scale across all health boards in Wales on completion.

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

This clinical trial aims to determine whether a ReDS-guided treatment strategy is superior to the current standard of care for adults hospitalized with heart failure. Additionally, the study will evaluate the safety and cost-effectiveness of this approach. The study seeks to answer the following key questions: 1. Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge? 2. What is the safety profile of this treatment strategy? Researchers will compare the ReDS-based strategy against the current standard of care. All participants will: * Undergo daily assessments using the ReDS device throughout their hospitalization. * Attend two follow-up visits post-discharge, scheduled at 2 weeks and 30 days.

Molecular Underpinnings of Heart Failure, Integrative Multi-Omics, and Non-Coding RNA Profiling

The main objective of the study is to achieve a comprehensive phenotyping of patients with heart failure, combining detailed clinical characterization with in-depth molecular profiling. By integrating clinical data with cutting-edge multi-omics techniques (including transcriptomics, epigenomics, and proteomics), this research aims to identify molecular signatures, particularly non-coding RNAs (ncRNAs), that are linked to the onset and progression of HF. Through advanced molecular profiling of biological samples and the analysis of clinical parameters, including advanced imaging, hemodynamic profiling, and biomarker analysis, the study will contribute to the deep phenotyping of HF patients. The secondary objective aims to uncover potential biomarkers that may serve as predictive indicators of disease progression and identify novel therapeutic targets, offering promising avenues for future treatments in this challenging patient population.