Patient-reported health status is an important assessment of patients with heart failure, but current approaches have substantial methodological and analytical limitations. Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) are commonly presented as a measure of the effect of drugs and devices, most often as the between-group difference in population means or as the odds of showing threshold changes of 5, 10, 15, and 20 points. However, the presentation of mean differences is based on statistical assumptions that are routinely violated in most trials. The presentation of threshold changes is based on the belief that a within-patient change in KCCQ of 5 points represents a significant treatment difference across diverse populations and trial settings, but the minimal clinically meaningful difference varies substantially depending on patient characteristics, comorbidities, and trial duration and design, with most values for minimally clinically important difference for KCCQ ranging from 10 to 20 points. Furthermore, the assessment of between-group differences is highly distorted by the assignment of a large proportion of randomized patients with very good health status as having substantially improved even if they showed no change after treatment. Any responder analysis is highly sensitive to differences in variance between the 2 treatment groups and cannot account for the stability of changes in the KCCQ score. The imposition of number-to-treat presentations onto KCCQ scores further compounds the lack of interpretability of reported changes. It is therefore not surprising that trials have reported substantial discrepancies between the effect of treatment on KCCQ and on the risk of hospitalizations for heart failure. In the FINEARTS (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure) trial, finerenone produced an 18% reduction in the risk of hospitalizations for heart failure but yielded uninterpretable and clinically questionable changes in KCCQ, with the small possibility of a modest benefit in <2% of randomized patients. Most physicians are unaware of the critically important methodological concerns summarized in the current paper, and, therefore, may make clinical decisions that hinge on unwarranted impressions of the effects of an intervention on health status.
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http://dx.doi.org/10.1016/j.jacc.2024.12.005 | DOI Listing |
JMIR Res Protoc
January 2025
School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.
Background: Heart failure (HF) is a chronic, progressive condition where the heart cannot pump enough blood to meet the body's needs. In addition to the daily challenges that HF poses, acute exacerbations can lead to costly hospitalizations and increased mortality. High health care costs and the burden of HF have led to the emerging application of new technologies to support people living with HF to stay well while living in the community.
View Article and Find Full Text PDFShock
January 2025
Department of Cardiology, The First Affiliated Hospital of Guangzhou Medical University; 151 Rd, Yan Jiang West, Guangzhou, 510120, China.
The global prevalence of heart failure is still growing, which imposes a heavy economic burden. The role of microRNA-146b (miR-146b) in HF remain largely unknown. This study aims to explore the role and mechanism of miR-146b in HF.
View Article and Find Full Text PDFPLoS One
January 2025
Hebei General Hospital, Shijiazhuang City, Hebei Province, P.R. China.
Objective: To study the effect of Dapagliflozin on ferroptosis in rabbits with chronic heart failure and to reveal its possible mechanism.
Methods: Nine healthy adult male New Zealand white rabbits were randomly divided into Sham group (only thorax opening was performed in Sham group, no ascending aorta circumferential ligation was performed), Heart failure group (HF group, ascending aorta circumferential ligation was performed in HF group to establish the animal model of heart failure), and Dapagliflozin group (DAPA group, after the rabbit chronic heart failure model was successfully made in DAPA group). Dapagliflozin was given by force-feeding method.
Eur J Prev Cardiol
January 2025
Department of Cardiology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, P. R. China.
Aim: To assess the relationship between body mass index (BMI), subcutaneous adipose tissue (SAT), visceral adipose tissue (VAT), epicardial adipose tissue (EAT), pericardial adipose tissue (PAT) and clinical outcomes in dilated cardiomyopathy (DCM) patients.
Methods: Non-ischemic DCM patients were prospectively enrolled. Regional adipose tissue, cardiac function, and myocardial tissue characteristics were measured by cardiac magnetic resonance (CMR).
Eur Heart J Acute Cardiovasc Care
January 2025
Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
Background: Closing the evidence-practice gap for the treatment of acute coronary syndrome (ACS) is central to improving quality of care. Under the European Society of Cardiology (ESC) framework, we aimed to develop updated quality indicators (QIs) for the evaluation of quality of care and outcomes for patients with ACS.
Methods: A Working Group of experts including members of the ESC Clinical Practice Guidelines Task Force for ACS, Acute CardioVascular Care Association and European Association of Percutaneous Cardiovascular Interventions followed the ESC methodology for QI development.
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