Kurdo Araz, Francesco Fioretti, Sara Ladak, Mohammed Obaidan, Javed Butler, Aamir Hameed
{"title":"在医疗器械和手术试验中保留射血分数的心力衰竭的表型特征。","authors":"Kurdo Araz, Francesco Fioretti, Sara Ladak, Mohammed Obaidan, Javed Butler, Aamir Hameed","doi":"10.1002/ehf2.15401","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>Heart failure with preserved ejection fraction (HFpEF) prevalence is nearing 50% of all heart failure cases and is often associated with advanced age, obesity, atrial fibrillation and hypertension, and medical approaches are limited. This review aims to determine the potential of medical devices or surgical interventions in treating HFpEF and to propose specific phenotypes of HFpEF.</p><p><strong>Methods and results: </strong>A systematic review was conducted using various clinical trial databases and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines followed by descriptive analysis and methodology quality assessment. Inclusion criteria included a medical device or surgical intervention involving HFpEF patients defined by a left ventricular ejection fraction (LVEF) ≥50% and signs of diastolic dysfunction. Twenty-four novel trials were identified involving n = 1752 participants: 17 medical device trials [3 interatrial shunt device trials (n = 1069), 1 atrial flow regulator trial (n = 41), 3 vagal nerve stimulation trials (n = 112), 1 baroreflex activation therapy trial (n = 21), 1 cardiac contractility modulator trial (n = 47), 6 cardiac resynchronization therapy trials (n = 178) and 2 functional electrical stimulation therapy trials (n = 89)] and 7 surgical intervention trials [1 renal denervation trial (n = 25), 3 greater splanchnic nerve ablation trials (n = 111), 2 catheter ablation trials (n = 55) and 1 pericardiotomy procedure trial (n = 4)]. One trial completed phase 3 trials, 20 trials completed phase 1 trials with further trials, and 5 trials completed phase 1 trials without further trials.</p><p><strong>Conclusions: </strong>Overall, 16 out of 24 trials have at least demonstrated safety and feasibility. However, despite many trials of a medical device or surgical procedure showing proof of concept to treat HFpEF phenotypes, they do not provide sufficient evidence of long-term benefit. More robust and phenotype-based clinical trials are needed to ensure evidence-based solutions are developed in HFpEF.</p>","PeriodicalId":11864,"journal":{"name":"ESC Heart Failure","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Phenotype characterization of heart failure with preserved ejection fraction in medical device and surgical trials.\",\"authors\":\"Kurdo Araz, Francesco Fioretti, Sara Ladak, Mohammed Obaidan, Javed Butler, Aamir Hameed\",\"doi\":\"10.1002/ehf2.15401\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>Heart failure with preserved ejection fraction (HFpEF) prevalence is nearing 50% of all heart failure cases and is often associated with advanced age, obesity, atrial fibrillation and hypertension, and medical approaches are limited. This review aims to determine the potential of medical devices or surgical interventions in treating HFpEF and to propose specific phenotypes of HFpEF.</p><p><strong>Methods and results: </strong>A systematic review was conducted using various clinical trial databases and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines followed by descriptive analysis and methodology quality assessment. Inclusion criteria included a medical device or surgical intervention involving HFpEF patients defined by a left ventricular ejection fraction (LVEF) ≥50% and signs of diastolic dysfunction. Twenty-four novel trials were identified involving n = 1752 participants: 17 medical device trials [3 interatrial shunt device trials (n = 1069), 1 atrial flow regulator trial (n = 41), 3 vagal nerve stimulation trials (n = 112), 1 baroreflex activation therapy trial (n = 21), 1 cardiac contractility modulator trial (n = 47), 6 cardiac resynchronization therapy trials (n = 178) and 2 functional electrical stimulation therapy trials (n = 89)] and 7 surgical intervention trials [1 renal denervation trial (n = 25), 3 greater splanchnic nerve ablation trials (n = 111), 2 catheter ablation trials (n = 55) and 1 pericardiotomy procedure trial (n = 4)]. One trial completed phase 3 trials, 20 trials completed phase 1 trials with further trials, and 5 trials completed phase 1 trials without further trials.</p><p><strong>Conclusions: </strong>Overall, 16 out of 24 trials have at least demonstrated safety and feasibility. However, despite many trials of a medical device or surgical procedure showing proof of concept to treat HFpEF phenotypes, they do not provide sufficient evidence of long-term benefit. More robust and phenotype-based clinical trials are needed to ensure evidence-based solutions are developed in HFpEF.</p>\",\"PeriodicalId\":11864,\"journal\":{\"name\":\"ESC Heart Failure\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-08-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ESC Heart Failure\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/ehf2.15401\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ESC Heart Failure","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/ehf2.15401","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Phenotype characterization of heart failure with preserved ejection fraction in medical device and surgical trials.
Aims: Heart failure with preserved ejection fraction (HFpEF) prevalence is nearing 50% of all heart failure cases and is often associated with advanced age, obesity, atrial fibrillation and hypertension, and medical approaches are limited. This review aims to determine the potential of medical devices or surgical interventions in treating HFpEF and to propose specific phenotypes of HFpEF.
Methods and results: A systematic review was conducted using various clinical trial databases and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines followed by descriptive analysis and methodology quality assessment. Inclusion criteria included a medical device or surgical intervention involving HFpEF patients defined by a left ventricular ejection fraction (LVEF) ≥50% and signs of diastolic dysfunction. Twenty-four novel trials were identified involving n = 1752 participants: 17 medical device trials [3 interatrial shunt device trials (n = 1069), 1 atrial flow regulator trial (n = 41), 3 vagal nerve stimulation trials (n = 112), 1 baroreflex activation therapy trial (n = 21), 1 cardiac contractility modulator trial (n = 47), 6 cardiac resynchronization therapy trials (n = 178) and 2 functional electrical stimulation therapy trials (n = 89)] and 7 surgical intervention trials [1 renal denervation trial (n = 25), 3 greater splanchnic nerve ablation trials (n = 111), 2 catheter ablation trials (n = 55) and 1 pericardiotomy procedure trial (n = 4)]. One trial completed phase 3 trials, 20 trials completed phase 1 trials with further trials, and 5 trials completed phase 1 trials without further trials.
Conclusions: Overall, 16 out of 24 trials have at least demonstrated safety and feasibility. However, despite many trials of a medical device or surgical procedure showing proof of concept to treat HFpEF phenotypes, they do not provide sufficient evidence of long-term benefit. More robust and phenotype-based clinical trials are needed to ensure evidence-based solutions are developed in HFpEF.
期刊介绍:
ESC Heart Failure is the open access journal of the Heart Failure Association of the European Society of Cardiology dedicated to the advancement of knowledge in the field of heart failure. The journal aims to improve the understanding, prevention, investigation and treatment of heart failure. Molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, as well as the clinical, social and population sciences all form part of the discipline that is heart failure. Accordingly, submission of manuscripts on basic, translational, clinical and population sciences is invited. Original contributions on nursing, care of the elderly, primary care, health economics and other specialist fields related to heart failure are also welcome, as are case reports that highlight interesting aspects of heart failure care and treatment.