Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in vascular endothelial function
研究概览
简要总结
The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •CRT Group: Patients recommended for CRT-P or CRT-D for heart failure (HF) according to current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines of Left Ventricle Ejection Fraction (LVEF)<35%, Left Bundle Branch Block (LBBB)>120 ms, New York Heart Association (NYHA) Class II-III).
- •Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks
排除标准
- •Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.
研究组 & 干预措施
Cardiac Resynchronization Therapy (CRT) Group
Participants undergoing Cardiac Resynchronization Therapy Implantation (CRT) implantation for heart failure as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue
干预措施: Subcutaneous adipose tissue collection (Procedure)
Cardiac Resynchronization Therapy (CRT) Group
Participants undergoing Cardiac Resynchronization Therapy Implantation (CRT) implantation for heart failure as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue
干预措施: Peripheral arterial tonometry (PAT) (Diagnostic Test)
Control Group
Participants undergoing device pacemaker or implantable cardioverter-defibrillator (ICD) implantation or pack change for sinus node dysfunction or Atrioventricular (AV) block as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue
干预措施: Subcutaneous adipose tissue collection (Procedure)
Control Group
Participants undergoing device pacemaker or implantable cardioverter-defibrillator (ICD) implantation or pack change for sinus node dysfunction or Atrioventricular (AV) block as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue
干预措施: Peripheral arterial tonometry (PAT) (Diagnostic Test)
结局指标
主要结局
Change in vascular endothelial function
时间窗: baseline, 3 months
Vascular endothelial function will be measured using peripheral arterial tonometry as the reactive hyperemia index (RHI) at baseline and at 3 months.
次要结局
未报告次要终点
研究者
Hon-Chi Lee, M.D., Ph.D.
Principal Investigator
Mayo Clinic