A Prospective, Multicenter, Observational, Investigator Initiated Study, Aiming at Serial Multiparametric Evaluation of Right Ventricular Function to Predict Optimal Management Strategies, of Right Heart Failure After LVAD Implantation
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 9
- 主要终点
- Moderate or severe RHF
研究概览
简要总结
The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and function in combination with comprehensive hemodynamic, laboratory and clinical parameters. The findings of the study will enhance prediction of early and late development of postoperative right-sided heart failure (RHF) and subsequent mortality and morbidity.
The secondary purpose of the study is to combine echocardiographic, hemodynamic, laboratory, and clinical data to define optimal management strategies of RHF after LVAD implantation.
详细描述
The study consists of 2 parts: a Pilot study and a Main Study as detailed below.
The purpose of the Pilot study is to evaluate the feasibility of RV quantification using two-, three-dimensional and Multiplane echocardiography.
About 100 subjects undergoing LVAD implantation in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) Registry are included in the Pilot study. These 100 patients will undergo routinely scheduled echocardiography before, within 1 week, 3 months and 1 year after LVAD implantation. Echocardiography will be performed using ultrasound machines that are capable of acquisition of two-, three-dimensional and Multiplane Echocardiography of the right ventricle.
Echocardiographic analysis will include three-dimensional quantification of the RV size and function as well as RV strain analysis in the Multiplane format as described in the Appendix Echocardiography Procedure Manual.
The Echocardiographic analyses of the first 50 patients, included in selected sites, will be used to further specify the protocol for image acquisition and analysis to be used in the Main Study. Furthermore, all sites will first enter 2 patients in the Pilot Study before they can participate in the Main Study. The echocardiographic results of these 2 patients will be assessed by the core lab for quality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects to be included in the study must meet the following inclusion criteria:
- •Consecutive patients accepted for elective LVAD implantation in the context of routine care
- •>17 years of age
- •Written informed consent (IC), either by the patient or by legal representatives
- •Treated with mainstream devices
排除标准
- 未提供
结局指标
主要结局
Moderate or severe RHF
时间窗: 12 months
RHF is defined by a triad of: 1. Clinical (right-sided congestion, with or without hypotension, or hypo-perfusion) 2. Imaging evidence (RV dilatation, new \> grade 2 tricuspid regurgitation) deterioration right ventricular function score assessed by the echocardiography core laboratory) 3. Hemodynamic evidence (discordant elevated central venous pressure (CVP) or right atrial pressure (RAP) \>16 mmHg, despite normal or steady pulmonary capillary wedge pressure (PCWP), or right atrial (RA) to PCWP ratio \>0.54).
次要结局
- Severe RHF composite(1 week, 30 days, 90 days, 180 days, 12 months)
- All-cause death(1 week, 30 days, 90 days, 180 days, 12 months)
- Cardiovascular death(1 week, 30 days, 90 days, 180 days, 12 months)
- Death or urgent transplantation(1 week, 30 days, 90 days, 180 days, 12 months)
- Length of post-operative Intensive Care Unit (ICU) stay(30 days, 90 days, 180 days, 12 months)
- Length of post-operative hospital stay(30 days, 90 days, 180 days, 12 months)
- Readmissions for heart failure or RHF(30 days, 90 days, 180 days, 12 months)
- Sepsis(1 week, 30 days, 90 days, 180 days, 12 months)
- LVAD and driveline-related infection(1 week, 30 days, 90 days, 180 days, 12 months)
- Early and late bleeding complications(1 week, 30 days, 90 days, 180 days, 12 months)
- LVAD pump thrombosis(1 week, 30 days, 90 days, 180 days, 12 months)
- Haemolysis(1 week, 30 days, 90 days, 180 days, 12 months)
- Arterial thromboembolic events, including stroke(1 week, 30 days, 90 days, 180 days, 12 months)
- Venous thromboembolic events, including deep venous thrombosis (DVT) and pulmonary embolism (PE)(1 week, 30 days, 90 days, 180 days, 12 months)
- Ventricular arrhythmias, either sustained symptomatic or with appropriate Implantable Cardioverter Defibrillator (ICD) therapy(1 week, 30 days, 90 days, 180 days, 12 months)
- Atrial arrhythmias - documented atrial flutter or fibrillation(1 week, 30 days, 90 days, 180 days, 12 months)
- Acute Kidney Injury (AKI) according to Kidney Disease Outcomes Quality Initiative (KDIGO) and RIFFLE criteria(1 week, 30 days, 90 days, 180 days, 12 months)
- Chronic kidney disease (CKD) according to KDOQI criteria(1 week, 30 days, 90 days, 180 days, 12 months)
- Six Minute walk distance in meters(90 days and 12 months)
- Quality of life (QoL) scores(90 days, 180 days and at 12 months)
研究者
I. Osama SOLIMAN
Assistant Professor of Cardiology
Erasmus Medical Center