Markers and Response to Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- Correlation of biomarkers with reverse remodeling in cardiac resynchronization therapy
研究概览
简要总结
The purpose of this study is to investigate: the relation of a set of (bio)markers and response to Cardiac Resynchronization Therapy (CRT); the interrelationship as well as the potential predictive power of these (bio)markers on improvement and/or deterioration of cardiac function, cardiac geometry (reverse re-modeling during CRT) will be evaluated.
(Bio)markers include but are not limited to: collagen, genomic markers, molecular markers, electrocardiographic markers, echocardiographic markers, arrhythmogenic markers and markers for renal function: blood urea nitrogen (BUN), serum creatinine, glomerular filtration rate (GFR).
详细描述
Title
MARC (Markers And Response to CRT) - Prospective CRT study
Sponsor and study management
The MARC study is being sponsored by all participants of the COHFAR project as being defined in the COHFAR project agreement (Medtronic, UMCU, AMC, MUMC, VUMC, UMCG and ICIN). Study management will be done by Medtronic.
Purpose
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is indicated for CRT-D device according to current applicable ESC/AHA guidelines
- •Subject has NYHA class II or III
- •Subject has stable sinus rhythm (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion) No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
- •Intrinsic QRS-width ≥ 130 ms with LBBB or ≥ 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class II
- •Intrinsic QRS-width ≥ 120 ms with LBBB or ≥ 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class III
- •Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
- •Subject is willing to sign informed consent form
- •Subject is 18 years or older
排除标准
- •Subject is upgraded from a bradycardia pacemaker to CRT-D
- •Subject receives CRT-D replacement or is upgraded from CRT-P to CRT-D
- •Subject has permanent atrial fibrillation/ flutter or tachycardia.
- •Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
- •Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
- •Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
- •Subject is implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
- •Subject is on chronic renal dialysis
- •Subject has severe renal disease (defined as Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2)
- •Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
- •Subject has RBBB
- •Subject has permanent 2nd or 3rd degree AV-block
- •Subject has severe aortic stenosis (with a valve area of < 1.0 cm2 or significant valve disease expected to be operated within study period)
- •Subject has complex and uncorrected congenital heart disease
- •Subject has a mechanical right heart valve
- •Subject has a life expectancy of less than one year in the opinion of the investigator
- •Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
- •Subject is enrolled in one or more concurrent studies that would confound the results of this study
结局指标
主要结局
Correlation of biomarkers with reverse remodeling in cardiac resynchronization therapy
时间窗: 6 months
To investigate the relationship between a set of (bio)markers and response to cardiac resynchronization therapy (as measured by echocardiography) at 6 months. For each biomarker, the relation with LVESVi change between baseline and 6 months post implant will be analyzed.
次要结局
- Correlation of biomarker with reverse remodeling in cardiac resynchronization therapy(12 months)
- Correlation of biomarkers with echocardiographic changes in cardiac resynchronization therapy(12 months)
- Correlation of anatomy and function with response to cardiac resynchronization therapy(12 months)
- Correlation of biomarkers and atrial fibrillation in cardiac resynchronization therapy(12 months)
- Correlation of biomarkers and ventricular arrhythmias in cardiac resynchronization therapy(12 months)