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.

心力衰竭（HF）和左心室功能障碍患者同时存在室性早搏（PVC）。 频繁的室性早搏已被证明会诱发可逆性心肌病（PVC-CM），但目前尚不清楚其中的原因。 回顾性和观察性研究表明，患者会出现 PVC-CM，而其他患者则不会。 通过射频消融 (RFA) 抑制 PVC 后改善左心室功能 因此，适当。 PVC-CM 患者的诊断和治疗被认为具有显着的益处，可以提高治疗质量 目前，这些患者接受 RFA、 抗心律失常药物（AAD）或不治疗取决于医生的经验和资源。 显然需要进行大型临床试验来比较这些治疗策略然而，我们需要更好地了解。 PVC-CM 的流行情况、此类试验的可行性和局限性。 本研究的长期目标是：1）确定抑制 PVC 的最佳治疗策略和 改善 PVC-CM，2) 比较临床获益（生活质量、心力衰竭症状/入院和不良事件） RFA 和 AAD 之间的比较，以及 3) 识别患者和 PVC 特征，这些特征容易导致 PVC- CM. 拟议试点研究的具体目标包括： 1) 估计 PVC-CM 的患病率 接受动态心电图监测的人群以及 2) 评估全面的可行性以及更好的设计和功效 我们认为，除了改善 CM 之外，RFA 还具有显着的临床益处。 与我们的试点研究爱好者相比，一年后效果更好，并发症更少。 PVC-CM 的患病率被低估，进行大型随机试验是可行的。 研究设计和方法。我们建议筛查 20,000 份连续动态心电图动态心电图。 对所有参与中心进行监测，以确定所有可能诊断为 PVC-CM 的患者（PVC 负荷 >10% 且 LVEF <45%）此外，我们还将开展一项临床试点研究，招募 30 名频繁发生 PVC 的患者。 （负担 >10%）和 CM（LVEF <45%），并将其随机分配至：1) RFA 或 2) AAD。 患者将接受基线心脏 MR 并有 3 个月的观察期（最佳 HF 医疗 我们计划跟踪左心室功能/疤痕、室性早搏负荷/心律失常和临床/功能状态的变化。 （QOL、心力衰竭症状和入院、NYHA 等级）和整个观察期间的不良事件以及 与 PVC 抑制策略（RFA 或 AAD）相比，RFA 和 AAD 之间也将进行类似的比较。 使用前瞻性随机开放、盲法终点进行 12 个月随访期间的 AAD 治疗组 （PROBE）研究设计将在意向治疗分析中进行比较。 这项试点研究旨在估计该临床实体的患病率，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。 低估的 PVC-CM 可能会改善患者的健康并随后减少 HF 医疗支出。