How to make cardiology clinical trials more inclusive.

Cardiovascular clinical trials continue to under-represent children, older adults, females and people from ethnic minority groups relative to population disease distribution. Here we describe strategies to foster trial representativeness, with proposed actions at the levels of trial funding, design, conduct and dissemination. In particular, trial representativeness may be increased through broad recruitment strategies and site selection criteria that reflect the diversity of patients in the catchment area, as well as limiting unjustified exclusion criteria and using pragmatic designs that minimize research burden on patients (including embedded and decentralized trials).

Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC).

Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions' selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence.

QRS detection in single-lead, telehealth electrocardiogram signals: Benchmarking open-source algorithms.

Background And Objectives: A key step in electrocardiogram (ECG) analysis is the detection of QRS complexes, particularly for arrhythmia detection. Telehealth ECGs present a new challenge for automated analysis as they are noisier than traditional clinical ECGs. The aim of this study was to identify the best-performing open-source QRS detector for use with telehealth ECGs.

Reliability of single-lead electrocardiogram interpretation to detect atrial fibrillation: insights from the SAFER feasibility study.

Aims: Single-lead electrocardiograms (ECGs) can be recorded using widely available devices such as smartwatches and handheld ECG recorders. Such devices have been approved for atrial fibrillation (AF) detection. However, little evidence exists on the reliability of single-lead ECG interpretation.

Randomised controlled trial of population screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the SAFER trial.

Introduction: There is a lack of evidence that the benefits of screening for atrial fibrillation (AF) outweigh the harms. Following the completion of the Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) pilot trial, the aim of the main SAFER trial is to establish whether population screening for AF reduces incidence of stroke risk.

Methods And Analysis: Approximately 82 000 people aged 70 years and over and not on oral anticoagulation are being recruited from general practices in England.

Temporal association of ventricular arrhythmias and respiratory events in heart failure patients with central sleep apnoea.

In contrast to obstructive sleep apnoea, the peak of sympathetic tone in central sleep apnoea occurs during the hyperventilation phase. To explore the temporal association of premature ventricular complex (PVC) burden in the context of the apnoea/hypopnoea-hyperpnoea cycle, the duration of apnoea/hypopnoea was defined as 100 %. We assessed the PVC burden throughout the apnoea/hypopnoea-hyperpnoea cycle during the periods of ±150 % in 50 % increments before and after the apnoea/hypopnoea phase.

Framework-based qualitative analysis of free responses of Large Language Models: Algorithmic fidelity.

Today, with the advent of Large-scale generative Language Models (LLMs) it is now possible to simulate free responses to interview questions such as those traditionally analyzed using qualitative research methods. Qualitative methodology encompasses a broad family of techniques involving manual analysis of open-ended interviews or conversations conducted freely in natural language. Here we consider whether artificial "silicon participants" generated by LLMs may be productively studied using qualitative analysis methods in such a way as to generate insights that could generalize to real human populations.

Wearable Sensors to Monitor Physical Activity in Heart Failure Clinical Trials: State-of-the-Art Review.

Background: Estimation of the effects that drugs or other interventions have on patients' symptoms and functions is crucial in heart failure trials. Traditional symptoms and functions clinical outcome assessments have important limitations. Actigraphy may help to overcome these limitations due to its objective nature and the potential for continuous recording of data.

Estimating the clinical and budgetary impact of using angiotensin receptor neprilysin inhibitor as first line therapy in patients with HFrEF.

Aims: Recent updates of international treatment guidelines for heart failure with reduced ejection fraction (HFrEF) differ regarding the use of angiotensin receptor neprilysin inhibitor (ARNI) as first-line treatment. The American Heart Association/American College of Cardiology/Heart Failure Society of America (AHA/ACC/HFSA) 2022 guidelines gives ARNI a Class IA recommendation for HFrEF patients while the European Society of Cardiology's guidelines are less clear when ARNI could be considered as first line treatment option in de novo patients. This study aimed to model the clinical and budgetary outcomes of implementing these guidelines, comparing conservative ARNI prescription patterns with less conservative in Sweden and in the United Kingdom.

Effect of implementing a heart failure admission care bundle on hospital readmission and mortality rates: interrupted time series study.

This study aimed to evaluate the impact of developing and implementing a care bundle intervention to improve care for patients with acute heart failure admitted to a large London hospital. The intervention comprised three elements, targeted within 24 hours of admission: N-terminal pro-B-type natriuretic peptide (NT-proBNP) test, transthoracic Doppler two-dimensional echocardiography and specialist review by cardiology team. The SHIFT-Evidence approach to quality improvement was used.

Predictors of outcome in a contemporary cardiac sarcoidosis population: Role of brain natriuretic peptide, left ventricular function and myocardial inflammation.

Aims: Cardiac sarcoidosis (CS) is a potentially fatal condition that varies in its clinical presentation. Here, we describe baseline characteristics at presentation along with prognosis and predictors of outcome in a sizable and deeply phenotyped contemporary cohort of CS patients.

Methods And Results: Consecutive CS patients seen at one institution were retrospectively enrolled after undergoing laboratory testing, electrocardiogram, echocardiography, cardiac magnetic resonance (CMR) imaging and F-flourodeoxyglucose positron emission tomography (FDG-PET) at baseline.

Circulating miR-133a-3p defines a low-risk subphenotype in patients with heart failure and central sleep apnea: a decision tree machine learning approach.

Background: Patients with heart failure with reduced ejection fraction (HFrEF) and central sleep apnea (CSA) are at a very high risk of fatal outcomes.

Objective: To test whether the circulating miRNome provides additional information for risk stratification on top of clinical predictors in patients with HFrEF and CSA.

Methods: The study included patients with HFrEF and CSA from the SERVE-HF trial.

The cost-effectiveness of NT-proBNP for assessment of suspected acute heart failure in the emergency department.

Aims: When relying on clinical assessment alone, an estimated 22% of acute heart failure (AHF) patients are missed, so clinical guidelines recommend the use of N-terminal pro-B-type natriuretic peptide (NT-proBNP) for AHF diagnosis. Since publication of these guidelines, there has been poor uptake of NT-proBNP testing in part due to concerns over excessive false positive referrals resulting from the low specificity of a single 'rule-out' threshold of <300 pg/mL. Low specificity can be mitigated by the addition of age-specific 'rule-in' NT-proBNP thresholds.

Associations between baseline heart rate and blood pressure and time to events in heart failure with reduced ejection fraction patients: Data from the QUALIFY international registry.

Aims: A high resting heart rate (RHR) and low systolic blood pressure (SBP) are a risk factor and a risk indicator, respectively, for poor heart failure (HF) outcomes. This analysis evaluated the associations between baseline RHR and SBP with outcomes and treatment patterns in patients with HF and reduced ejection fraction (HFrEF) in the QUALIFY (QUality of Adherence to guideline recommendations for LIFe-saving treatment in heart failure surveY) international registry.

Methods And Results: Between September 2013 and December 2014, 7317 HFrEF patients with a previous HF hospitalization within 1-15 months were enrolled in the QUALIFY registry.

Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management.

Patient-reported outcomes (PROs) provide important insights into patients' own perspectives about their health and medical condition, and there is evidence that their use can lead to improvements in the quality of care and to better-informed clinical decisions. Their application in cardiovascular populations has grown over the past decades. This statement describes what PROs are, and it provides an inventory of disease-specific and domain-specific PROs that have been developed for cardiovascular populations.

Real-time pulmonary artery pressure monitoring in heart failure patients: an updated cost-effectiveness analysis.

Aims: Previous cost-effectiveness analysis suggests that CardioMEMS is cost-effective compared with usual care for patients with persistent New York Heart Association class III symptoms and at least one heart failure (HF) hospitalization within 12 months. The aim of the paper is to perform an update of the cost-effectiveness analysis of CardioMEMS using the most recent data from the published literature.

Methods And Results: A Microsoft Excel Markov model from a previous UK cost-effectiveness study of CardioMEMS was updated using the clinical effectiveness of pulmonary artery pressure (PAP)-guided treatment derived from the pivotal trials.

Benefits and challenges of telemedicine for heart failure consultations: a qualitative study.

Background: Prior to the Covid-19 pandemic, heart failure (HF) disease management programmes were predominantly delivered in-person, with telemedicine being uncommon. Covid-19 resulted in a rapid shift to "remote-by-default" clinic appointments in many organisations. We evaluated clinician and patient experiences of teleconsultations for HF.

Personalized care of patients with heart failure: are we ready for a REWOLUTION? Insights from two international surveys on healthcare professionals' needs and patients' perceptions.

Aims: Guidelines for the management of heart failure (HF) are evolving, and increasing emphasis is placed on patient-centred care. As part of the REWOLUTION HF (REal WOrLd EdUcaTION in HF) programme, we conducted two international surveys aimed at assessing healthcare professionals' (HCPs) educational needs and patients' perspectives on the care of HF.

Methods And Results: Anonymous online questionnaires co-developed by HF experts and patients assessed HCPs' educational needs (520 respondents, mostly cardiologists, in 67 countries) and patients' perceptions on HF impact and management (98 respondents in 18 countries).

ESC Working Group on e-Cardiology Position Paper: accuracy and reliability of electrocardiogram monitoring in the detection of atrial fibrillation in cryptogenic stroke patients: In collaboration with the Council on Stroke, the European Heart Rhythm Association, and the Digital Health Committee.

The role of subclinical atrial fibrillation as a cause of cryptogenic stroke is unambiguously established. Long-term electrocardiogram (ECG) monitoring remains the sole method for determining its presence following a negative initial workup. This position paper of the European Society of Cardiology Working Group on e-Cardiology first presents the definition, epidemiology, and clinical impact of cryptogenic ischaemic stroke, as well as its aetiopathogenic association with occult atrial fibrillation.

Cluster randomised controlled trial of screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the pilot study for the SAFER trial.

Introduction: Atrial fibrillation (AF) is a common arrhythmia associated with 30% of strokes, as well as other cardiovascular disease, dementia and death. AF meets many criteria for screening, but there is limited evidence that AF screening reduces stroke. Consequently, no countries recommend national screening programmes for AF.

CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research.

Big data is central to new developments in global clinical science aiming to improve the lives of patients. Technological advances have led to the routine use of structured electronic healthcare records with the potential to address key gaps in clinical evidence. The covid-19 pandemic has demonstrated the potential of big data and related analytics, but also important pitfalls.