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临床试验/NCT01573091
NCT01573091已完成不适用

Cardiac Resynchronization Therapy Modular Registry

Giuseppe Ricciardi12 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
12
主要终点
Clinical response

研究概览

简要总结

The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

详细描述

Heart failure is a complex clinical syndrome characterized by a high prevalence and incidence in populations at greatest risk and, therefore, with a significant social and economic impact. Randomized clinical trials, meta-analyzes, observational studies and controlled trials clearly demonstrated that the neuro-hormonal therapy is highly effective in reducing mortality, hospitalization and improving quality of life. In recent years the electrical therapy is playing an increasingly important role in the treatment of patients with chronic heart failure. Such importance is mainly due to the possibility of preventing sudden cardiac death by implanting an ICD and to correct the deleterious effects of electrical dyssynchrony and / or left ventricular mechanics by CRT. The CRT has proven an effective tool in reducing mortality, reducing symptoms and improving quality of life in patients already receiving optimal medical therapy. Despite the undoubted benefits that the electrical treatment has added to conventional medical therapy, a high percentage of patients does not benefit in terms of clinical and echocardiographic. The identification of non-responders to CRT is crucial in order not to submit the patients to an unnecessary and costly device whose electrical therapy proves to be ineffective. The reason for lack of response is still unclear but factors such as lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Chronic symptomatic HF despite stable, optimal drug therapy
  • Indication for a cardiac resynchronisation device with or without defibrillator backup according to current guidelines
  • Patients implanted with cardiac resynchronization device

排除标准

  • Patients participating in other studies that clearly impact the clinical practice of the center
  • Patients who are unable to provide informed consent
  • Patients who can not perform follow-up in the center

结局指标

主要结局

Clinical response

时间窗: 24 months

Improvement in functional class status by at least one NYHA Class or remain in functional class II

Echocardiographic response of absolute increase of ≥5% in LVEF

时间窗: 24 months

Patients at follow-up to 6-12 months show an increase of the absolute value of the LVEF than 5%

Echocardiographic response of ≥15% reduction in LVESV

时间窗: 24 months

Patients at follow-up to 6-12 months show a systolic volume (LVESV) reduction greater than 15%

次要结局

  • Number of ventricular arrhythmias after cardiac resynchronization therapy(24 months)
  • LV lead/RV lead geometric distance(12 months)
  • Change from baseline in R wave in 12-lead ECG at 12 months(12 months)

研究者

发起方
Giuseppe Ricciardi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Giuseppe Ricciardi

Principal Investigator

University of Florence

研究点 (12)

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