Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS): A Pilot Study

心肌病 (PAPS) 室性早搏抑制的前瞻性评估：初步研究

• 批准号: 9372611
• 负责人: Teresa De Marco
• 金额: $ 23.6万
• 依托单位: RICHMOND INSTITUTE FOR VETERANS RESEARCH
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9372611
• 关键词: Ablation; Admission activity; Adverse effects; Adverse event; Affect; Anti-Arrhythmia Agents; Arrhythmia; Blinded; Cardiac; Cardiomyopathies; Cessation of life; Cicatrix; Clinical; Clinical Research; Clinical Trials; Development; Diagnosis; Drops; Electrocardiogram; Enrollment; Functional disorder; Health; Health Care Costs; Healthcare; Heart failure; Holter Electrocardiography; Intention; Left Ventricular Ejection Fraction; Life Expectancy; Medical; Methods; Morbidity - disease rate; Multicenter Studies; Observational Study; Outcome; Participant; Patients; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Pilot Projects; Population; Prevalence; Procedures; Prospective Studies; Quality of life; Radiofrequency Interstitial Ablation; Randomized; Randomized Clinical Trials; Research Design; Research Methodology; Resources; Rest; Retrospective Studies; Risk; Symptoms; Testing; Treatment Protocols; Ventricular Premature Complexes; active method; design; experience; follow-up; functional status; heart function; improved; improved functioning; interdisciplinary approach; mortality; multidisciplinary; outcome forecast; patient population; prospective; randomized trial; response; treatment group; treatment strategy; trial comparing

Premature ventricular contractions (PVCs) coexist in patients with heart failure (HF) and LV dysfunction. Frequent PVCs have shown to induce a reversible cardiomyopathy (PVC-CM). Yet, it is unclear why some patients develop PVC-CM, while others do not. Retrospective and observational studies have shown improvement of LV function after PVC suppression via radiofrequency ablation (RFA). Thus, appropriate diagnosis and treatment of patients with PVC-CM is believed to carry significant benefits, improving quality of life (QOL), HF symptoms / admissions and life expectancy. Currently, these patients are offered RFA, antiarrhythmic drugs (AADs) or no treatment depending on physician’s experience and resources. Thus, there is clear need for a large clinical trial comparing these treatment strategies. Yet, we need to better understand prevalence of PVC-CM, feasibility and limitations of such a trial. The long-term objectives of this study are to: 1) identify the best treatment strategy to suppress PVCs and improve PVC-CM, 2) compare the clinical benefits (quality of life, HF symptoms / admissions and adverse events) between RFA and AADs, and 3) identify patients and PVC features that predispose to the development of PVC- CM. The specific aims of the proposed pilot study include: 1) estimate the prevalence of PVC-CM in population receiving Holter monitors and 2) assess the feasibility and better design and power of a full scale large randomized study. We hypothesize that RFA has significant clinical benefits, besides improvement in CM with better outcomes and lower complications at 1 year when compared to AADs. Our pilot study hypothesizes that the prevalence of PVC-CM is underestimated and conducting a large randomized trial is feasible. Research Design and Methods. We propose to screen 20,000 consecutive ambulatory ECG Holter monitors of all participating centers to identify all patients with probable diagnosis of PVC-CM (PVC burden >10% and LVEF <45%). In addition, we will conduct a clinical pilot study, enrolling 30 patients with frequent PVCs (burden >10%) and CM (LVEF <45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, all patients will undergo a baseline cardiac MR and be allowed a 3-month observation period (optimal HF medical therapy). We plan to follow change in LV function/scar, PVC burden/arrhythmias and clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events throughout the observation period and compare with PVC suppression strategies (RFA or AAD). Similar comparison will be made between RFA and AAD treatment groups during a 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE) study design. The treatment regimens will be compared in an intention-to-treat analysis. This pilot study is intended to estimate the prevalence of this clinical entity and pave the way for a large full scale randomized trial to identify best treatment strategy for patients with PVC-CM. Treating and reversing this underestimated PVC-CM may improve patient’s health and subsequently decrease HF healthcare spending.

室性早搏(PVCs)在心力衰竭(HF)和左心功能不全患者中并存。 频繁的静脉曲张可诱发可逆性心肌病(PVC-CM)。然而，目前还不清楚为什么有些人 患者会发展为PVC-CM，而其他患者则不会。回顾和观察研究表明 射频消融术(RFA)消融后左室功能的改善。因此，适当的 诊断和治疗PVC-CM患者被认为具有显著的好处，提高了治疗质量 寿命(QOL)、心力衰竭症状/入院时间和预期寿命。目前，这些患者接受RFA， 抗心律失常药物(AADS)或不治疗取决于医生的经验和资源。因此，在那里 显然需要一项大规模的临床试验来比较这些治疗策略。然而，我们需要更好地理解 聚氯乙烯-CM的流行率、此类试验的可行性和局限性。 这项研究的长期目标是：1)确定抑制静脉曲张和 改善PVC-CM，2)比较临床益处(生活质量、心力衰竭症状/入院时间和不良事件) 在RFA和AADS之间，以及3)识别患者和容易发生PVC的PVC特征- 厘米。拟议的试点研究的具体目标包括：1)估计在 接受Holter监护仪的人口和2)评估全面量表的可行性和更好的设计和能力 大型随机研究。我们假设，除了改善CM外，RFA还有显著的临床益处 与AADS相比，1年后预后更好，并发症更少。我们的初步研究假设 PVC-CM的流行率被低估了，进行大规模随机试验是可行的。 研究设计与方法。我们建议连续筛查20,000个动态心电图仪 所有参与中心的监测仪，以确定所有可能诊断为PVC-CM的患者(PVC负担&>10% 和LVEF&lt；45%)。此外，我们还将进行一项临床先导性研究，纳入30名经常发生静脉血栓的患者。 (Burden&gt；10%)和CM(LVEF&lt；45%)，并将它们随机分为：1)RFA或2)AADS。在治疗前，所有人 患者将接受基线心脏磁共振，并允许3个月的观察期(最佳心力衰竭医疗 治疗)。我们计划跟踪左心功能/疤痕、室性心动过速负荷/心律失常和临床/功能状态的变化。 (生活质量、心衰症状和入院，NYHA级)和不良事件 请比较PVC抑制策略(RFA或AAD)。将在RFA和RFA之间进行类似的比较 使用前瞻性随机开放、盲目终点的12个月随访期间的AAD治疗组 (探索性)研究设计。治疗方案将在意向治疗分析中进行比较。 这项初步研究旨在评估这种临床实体的患病率，并为大规模全面研究铺平道路。 规模随机试验，以确定PVC-CM患者的最佳治疗策略。治疗和逆转这一现象 被低估的PVC-CM可能会改善患者的健康，从而减少HF的医疗支出。