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Optivol Diagnostic Data for Discharge in Heart Failure (3DHF)

2010年8月18日更新者：Thomas Jefferson University

Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness

The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in conjunction with other traditional clinical practice methods to determine if heart failure patients are ready for hospital discharge.

研究概览

地位

完全的

条件

详细说明

Implantable cardioverter defibrillator (ICD) devices with or without cardiac resynchronization therapy (CRT-D) have the ability to continuously monitor heart rate variability, daily heart rate, and patient activity. Changes in these measures have been associated with heart failure prognosis. In addition, ICD or CRT-D devices also have the ability to measure daily intrathoracic impedance. Previous data have demonstrated that device-based intrathoracic impedance measurements correlate with pulmonary capillary wedge pressure and fluid retention, both of which are common measures of heart failure status. The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance can be used in conjunction with other methods to determine if patients are ready for hospital discharge. This will be the first step in potentially developing an inpatient care strategy which includes implantable device data. It is hypothesized that device diagnostic data will identify an appropriate and safe time to discharge patients admitted for worsening heart failure symptoms before usual clinical indicators. More specifically, we hypothesize that device data will "normalize" at least one day prior to the clinical indicators of readiness for discharge and patients discharged prior to "normalization" of the device data will be at greater risk for rehospitalization

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Missouri
  - St. Joseph、Missouri、美国、64506
    - Heartland Health
- New Jersey
  - Elmer、New Jersey、美国、083618
    - Cardiovascular Associates of Delaware Valley
- Pennsylvania
  - Philadelphia、Pennsylvania、美国、19107
    - Thomas Jefferson University
  - Philadelphia、Pennsylvania、美国、19140
    - Temple University
  - Wynnewood、Pennsylvania、美国、19096
    - Main Line Health Lankenau Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

The study population is hospitalized patients who have an implanted Medtronic device with Optivol capability.

描述

Inclusion Criteria:

Patients implanted with a Medtronic InSync Sentry or subsequent FDA-approved Medtronic device with the OptiVol capability for >30 days.
Anticipated hospitalization stay >48 hours
Hospitalized patients experiencing worsening heart failure with symptoms of lung/pulmonary congestion.

Exclusion Criteria:

Anemia - admission hemoglobin <8.0 g/dL
Patients residing in convalescence center prior to admission or known to be discharged to a convalescence center or hospice, where discharge could be based on bed availability

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：队列
时间观点：预期

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Thomas Jefferson University

合作者

Medtronic

调查人员

首席研究员：David J Whellan, MD MHS、Thomas Jefferson University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年12月1日

初级完成 (实际的)

2010年2月1日

研究完成 (实际的)

2010年2月1日

研究注册日期

首次提交

2007年1月8日

首先提交符合 QC 标准的