Randomized, Crossover Study of the Effects of MultiPoint Left Ventricular Pacing on Neurohormonal Activation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP)
研究概览
简要总结
This study will examine the additional clinical benefit conferred by multipoint pacing (MPP) compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs. OFF and followed for a total of 6 months. This includes two crossover periods for each pacing modality (MPP on vs. off).
详细描述
Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders. Pacing activation from multiple separated left ventricular (LV) sites might improve the depolarization pattern, thereby promoting more physiological activation. To explore the effect of MPP on cardiac neuro-hormonal activity, the investigators will enroll approximately 30 patients who already underwent CRT-D implantation with a quadripolar LV lead connected to a device capable of MPP.
This pilot study will have a randomized, double-blind, cross-over design. Patients will be randomized to receive either standard biventricular pacing (MPP-OFF) or MPP (MPP-ON) within 4-6 months following the implantation procedure. Each subject will crossover to the other study group after three months. The baseline evaluation should be acquired prior to the device being programmed to the randomized setting. Repeat evaluations will be performed at the end of each 3 month crossover period.
Participation in this study will last approximately 6 months. Patients, as well as investigators other than the EP physicians, will be blinded to the pacing mode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients implanted with a St. Jude Medical CRT-D system with MPP capability
- •Patients must be willing and able to sign an appropriate informed consent form and comply with study requirements
- •NT pro-BNP levels equal to or greater than 500 pg/ml.
排除标准
- •History of stroke, PCI, myocardial infarction or unstable angina pectoris within the last 3 months.
- •Atrial fibrillation with noncontrolled heart rate
- •Need for intravenous inotropic support for CHF
- •Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
- •Undergone a cardiac transplantation
- •Currently participating in any other clinical investigation
- •Life expectancy < 12 months due to a disorder other than CHF
- •Inability to comply with the follow-up procedures
- •Patients who are or may potentially be pregnant
研究组 & 干预措施
MultiPoint Pacing "On"
Patients will be randomized to the MPP-ON Arm vs MPP-OFF in in crossover fashion with 3 months in each period.
干预措施: Cardiac Resynchronization Therapy with MultiPoint Pacing (Device)
MultiPoint Pacing "Off"
Patients will be randomized to the MPP-OFF arm vs MPP-ON in crossover fashion with 3 months in each period.
干预措施: Cardiac Resynchronization Therapy with MultiPoint Pacing (Device)
结局指标
主要结局
Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP)
时间窗: Baseline. 3-Month. 6-Month.
Changes in plasma NT pro-BNP using the difference from baseline to three months as compared to the difference from three to six months within a patient.
次要结局
- Echocardiographic changes(Baseline. 3-Month. 6-Month.)
- Flow-mediated vasodilation(Baseline. 3-month. 6-month)
- Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire(Baseline. 3-Month. 6-Month.)
- Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]).(3-Month. 6-Month.)
- Packer's clinical composite score(Baseline. 3-month. 6-month.)
- Appropriate device interventions (anti-tachycardia pacing or shock)(3-Month. 6-Month.)
- 6-Minute-Walking-Distance(Baseline. 3 Month. 6 Month.)
- Changes in Neurohormonal Activation(Baseline. 3-Month. 6-Month.)
- Heart Failure Hospitalizations(3-Month. 6-Month.)
- New York Heart Association (NYHA) Class changes(Baseline. 3-Month. 6-Month.)
- Phrenic Nerve Complication Free Rate(3-Month. 6-Month.)
研究者
Giovanni B Forleo
MD, PhD.
University of Rome Tor Vergata