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View article: Machine learning-enabled systematic review on coded healthcare data in heart failure research
Machine learning-enabled systematic review on coded healthcare data in heart failure research Open
Aims Coded healthcare data are now commonly used in clinical research. This study aimed to assess the transparency of reporting within heart failure studies and employ machine learning to facilitate larger-scale evaluation. Methods & Resul…
View article: Patient-Reported Experience Measures to Evaluate Digitally Supported Care Processes for Heart Failure: A Scoping Review
Patient-Reported Experience Measures to Evaluate Digitally Supported Care Processes for Heart Failure: A Scoping Review Open
Introduction: The integration of Patient-Reported Experience Measures (PREM) alongside traditional clinical outcomes is crucial for improving quality of care. Although PREMs are frequently measured in inpatient treatment settings, they are…
View article: Key Considerations for Designing Clinical Studies to Evaluate Digital Health Solutions
Key Considerations for Designing Clinical Studies to Evaluate Digital Health Solutions Open
Evidence of clinical impact is critical to unlock the potential of digital health solutions (DHSs), yet many solutions are failing to deliver positive clinical results. We argue in this viewpoint that this failure is linked to current appr…
View article: Rationale and design of the PACIFIC-PRESERVED (PhenomApping, ClassIFication and Innovation for Cardiac dysfunction in patients with heart failure and PRESERVED left ventricular ejection fraction) study
Rationale and design of the PACIFIC-PRESERVED (PhenomApping, ClassIFication and Innovation for Cardiac dysfunction in patients with heart failure and PRESERVED left ventricular ejection fraction) study Open
Heart failure with preserved ejection fraction (HFpEF) is a heterogeneous syndrome that is poorly defined, reflecting an incomplete understanding of its pathophysiology.
View article: Key Considerations for Designing Clinical Studies to Evaluate Digital Health Solutions (Preprint)
Key Considerations for Designing Clinical Studies to Evaluate Digital Health Solutions (Preprint) Open
UNSTRUCTURED Evidence of clinical impact is critical to unlock the potential of digital health solutions (DHSs), yet many solutions are failing to deliver positive clinical results. We argue in this viewpoint that this failure is linked t…
View article: Incidence of major cardiovascular outcomes in patients with chronic kidney disease by severity: a United States population-based study using electronic medical records
Incidence of major cardiovascular outcomes in patients with chronic kidney disease by severity: a United States population-based study using electronic medical records Open
Background and Aims Data on the incidence of cardiovascular (CV) events by stage of chronic kidney disease (CKD) and the effect of previous CV history on future events in CKD patients (pts) is limited. We aimed to analyze a large US electr…
View article: Unraveling the relationships between alpha- and beta-adrenergic modulation and the risk of heart failure
Unraveling the relationships between alpha- and beta-adrenergic modulation and the risk of heart failure Open
Background The effects of α and ß adrenergic receptor modulation on the risk of developing heart failure (HF) remains uncertain due to a lack of randomized controlled trials. This study aimed to estimate the effects of α and ß adrenergic r…
View article: “Click and mortar” opportunities for digitization and consumerism in trials
“Click and mortar” opportunities for digitization and consumerism in trials Open
We offer expert guidance and three "click and mortar" approaches to digital, consumer-oriented trials. More guidance and research are needed to navigate the associated opportunities and challenges.
View article: #2977 PROGRESSION AND REGRESSION OF CHRONIC KIDNEY DISEASE IN THE UNITED STATES USING ELECTRONIC MEDICAL RECORDS
#2977 PROGRESSION AND REGRESSION OF CHRONIC KIDNEY DISEASE IN THE UNITED STATES USING ELECTRONIC MEDICAL RECORDS Open
Background and Aims Chronic kidney disease (CKD) is generally considered to be progressive and may lead to end-stage kidney disease (ESKD), or death. We aim to analyze a large US database and capture CKD progression, regression, ESKD and d…
View article: Identifying subtypes of heart failure from three electronic health record sources with machine learning: an external, prognostic, and genetic validation study
Identifying subtypes of heart failure from three electronic health record sources with machine learning: an external, prognostic, and genetic validation study Open
European Union Innovative Medicines Initiative-2.
View article: Sex Differences in the Generalizability of Randomized Clinical Trials in Heart Failure with Reduced Ejection Fraction
Sex Differences in the Generalizability of Randomized Clinical Trials in Heart Failure with Reduced Ejection Fraction Open
Aims In order to understand how sex differences impact the generalizability of randomized clinical trials (RCTs) in patients with heart failure (HF) and reduced ejection fraction (HFrEF), we sought to compare clinical characteristics and c…
View article: Insulin-like growth factor-binding protein-7 (IGFBP7) links senescence to heart failure
Insulin-like growth factor-binding protein-7 (IGFBP7) links senescence to heart failure Open
Heart failure (HF) is a rising global cardiovascular epidemic driven by aging and chronic inflammation. As elderly populations continue to increase, precision treatments for age-related cardiac decline are urgently needed. Here we report t…
View article: CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research
CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research Open
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 ga…
View article: Identifying subtypes of heart failure with machine learning: external, prognostic and genetic validation in three electronic health record sources with 320,863 individuals
Identifying subtypes of heart failure with machine learning: external, prognostic and genetic validation in three electronic health record sources with 320,863 individuals Open
Background Reliable identification of heart failure (HF) subtypes might allow targeted management. Machine learning (ML) has been used to explore HF subtypes, but neither across large, independent, population-based datasets, nor across the…
View article: What Is Normal for an Aging Heart?: A Prospective CMR Cohort Study
What Is Normal for an Aging Heart?: A Prospective CMR Cohort Study Open
EudraCT Identifier: EudraCT 2017-000045-42.
View article: A population‐based study of 92 clinically recognized risk factors for heart failure: co‐occurrence, prognosis and preventive potential
A population‐based study of 92 clinically recognized risk factors for heart failure: co‐occurrence, prognosis and preventive potential Open
Aims Primary prevention strategies for heart failure (HF) have had limited success, possibly due to a wide range of underlying risk factors (RFs). Systematic evaluations of the prognostic burden and preventive potential across this wide ra…
View article: Generalizability of randomized controlled trials in heart failure with reduced ejection fraction
Generalizability of randomized controlled trials in heart failure with reduced ejection fraction Open
Background Heart failure (HF) trials have stringent inclusion and exclusion criteria, but limited data exist regarding generalizability of trials. We compared patient characteristics and outcomes between patients with HF and reduced ejecti…
View article: Use of Actigraphy (Wearable Digital Sensors to Monitor Activity) in Heart Failure Randomized Clinical Trials: A Scoping Review
Use of Actigraphy (Wearable Digital Sensors to Monitor Activity) in Heart Failure Randomized Clinical Trials: A Scoping Review Open
There is significant heterogeneity in the use, methodology, and results of actigraphy-based HF RCTs. Our results highlight the need to develop, standardize, and validate actigraphy-specific outcomes for use in HF clinical trials.
View article: A genetic model of ivabradine recapitulates results from randomized clinical trials
A genetic model of ivabradine recapitulates results from randomized clinical trials Open
Genetic modelling of ivabradine recapitulates its benefits in heart failure, promotion of atrial fibrillation, and neutral effect on myocardial infarction.
View article: Comparison of Outcome Adjudication by Investigators and by a Central End Point Committee in Heart Failure Trials
Comparison of Outcome Adjudication by Investigators and by a Central End Point Committee in Heart Failure Trials Open
Background: The usefulness of adjudication by central end point committees (CECs) is poorly assessed in heart failure (HF) trials. We aimed to assess its impact on the outcome of the SHIFT trial (Systolic HF Treatment With the If Inhibitor…
View article: Genetic drug target validation using Mendelian randomization
Genetic drug target validation using Mendelian randomization Open
Mendelian randomisation analysis has emerged as an important tool to elucidate the causal relevance of a range of environmental and biological risk factors for human disease. However, inference on cause is undermined if the genetic variant…
View article: A randomized, double-blind, placebo-controlled trial assessing the efficacy of S66913 in patients with paroxysmal atrial fibrillation
A randomized, double-blind, placebo-controlled trial assessing the efficacy of S66913 in patients with paroxysmal atrial fibrillation Open
DIAGRAF-IKUR was the first study to show that using ICM to assess the effect of an AAD is feasible. The selective IKur inhibitor S66913 was safe but had no clinically meaningful effect at the time of early termination of the study.
View article: New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment
New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment Open
Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline …