A Study to Evaluate the Effects of EECP in Patients With Heart Failure
An Open-label Study to Evaluate the Effects of Enhanced External Counterpulsation on Tapering Inotropic Agents, Reduction of Brain Natriuretic Peptide and Rehospitalization in Patients With Heart Failure
研究概览
详细说明
Chronic heart failure (CHF) patients dependent on intravenous infusion of positive inotropic agents have not only high mortality rate but also high morbidity in the prolonged hospital course. Medications such as angiotensin conversion enzyme inhibitor or angiotensin II receptor blocker may improve the survival of CHF patients. However, their implication is limited by the presence of hypotension secondary to low cardiac output. External enhanced counterpulsation (EECP), which generates the arterial and intracoronary hemodynamics similar to those of the intra-aortic balloon pump, is a recently approved treatment modality for patients with angina and heart failure. It can improve exercise capacity, quality of life and functional status.
Forty patients of (1) impaired left ventricular systolic function (LVEF 40%) and are dependent on intravenous infusion of positive inotropic agents but (2) without significant aortic regurgitation, overt fluid overload, or symptomatic peripheral arterial insufficiency will be included. They will be randomly allocated into EECP or control groups (n=20 for each). The EECP therapy was given as a 1-hour session, once daily, for a total of 35 sessions. The daily urine amount, blood pressure, time for taper off positive inotropic agents, length of hospital stay, and will be monitored daily in the hospital stay. Patients will be followed-up if he or she can be released from hospital and the mortality, readmission for heart failure, and 6-minute walking distance will be checked at the end of 6th month. Plasma natriuretic peptide (BNP) levels will be checked at enrollment, day 35, and 6th month.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Taipei、台湾、10002
- 招聘中
- National Taiwan University Hospital
-
接触：
- Chii-Ming Lee
- 电话号码：0972-651-087
- 邮箱：chiiminglee@ntu.edu.tw
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria All answers must be "Yes" for study entry.
- Male or female patients between 21-80 years of age.
- Patients who have documented evidence of HF.
Evidence of HF required at least one of the following:
LVEF <40%. As assessed with 3 months prior to enrollment, and LVEF can be measured through echocardiogram or radionuclide angiocardiography (RNA); Clinical symptoms of HF, namely the presence of 2 major criteria or 1 major criterion + 2 minor criteria according to the Framingham score; NYHA Fc III or IV ACC/AHA stage D 3. Treated with inotropic agents. Inotropic agents include dopamine, dobutamine, milrinone, norepinephrine. Low dose is included as well. 4. Patients who sign the informed consent . Exclusion criteria All answers must be "No" for study entry.
- Patients who had MI or coronary artery bypass grafting (CABG) within three months prior to the initiation of EECP treatment.
- Patients who had transcatheter intervention (PCI) within 2 weeks prior to the initiation of EECP treatment.
- Significant valvular heart disease, acute myocarditis.
- Uncontrolled hypertension (blood pressure 180/100 mmHg).
- Permanent pacemakers or implantable cardioverter defibrillators.
- Non bypassed left main coronary with a luminal stenosis greater than 50%.
- Severe symptomatic peripheral vascular disease.
- History of deep vein thrombosis.
- Phlebitis or stasis ulcer.
- Bleeding diathesis, warfarin use with International Normalized Ratio 2.0.
- Arial fibrillation or frequent ventricular premature beats that interferes with enhanced external counterpulsation triggering.
- Baseline ECG abnormalities that would interfere with interpretation of exercise ECG.
- Pregnant women, or women of childbearing potential but not using adequate birth control.
- Any medical, psychological, cognitive, social or legal condition that would interfere with the ability of patient to give an Informed Consent and/or his or her capacity to comply with all study requirements, including the necessary time commitment.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Enhanced External Counterpulsation
Subjects of Heart failure with 'Enhanced External Counterpulsation" therapy
|
The EECP therapy was given as a 1-hour session, once daily, for a total of 35 sessions.
The daily urine amount, blood pressure, time for taper off positive inotropic agents, length of hospital stay, and will be monitored daily in the hospital stay.
Patients will be followed-up if he or she can be released from hospital and the mortality, readmission for heart failure, and 6-minute walking distance will be checked at the end of 6th month.
Plasma natriuretic peptide (BNP) or N-terminal pro-brain natriuretic peptide (NT-pro-BNP) levels will be checked at enrollment, day 35, and 6th month.
其他名称：
|
|
无干预：No 'Enhanced External Counterpulsation"
Subjects of Heart failure without 'Enhanced External Counterpulsation" therapy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the natriuretic peptide (NT-pro-BNP) level will be reduced.
大体时间：7 week
|
the natriuretic peptide (NT-pro-BNP) level will be reduced
|
7 week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weaning from intravenous infusion of positive inotropic agent
大体时间：24 week
|
Weaning from intravenous infusion of positive inotropic agent
|
24 week
|
|
Decrease the length of hospital stay.
大体时间：24 week
|
Decrease the length of hospital stay.
|
24 week
|
合作者和调查者
调查人员
- 首席研究员：Chii-Ming Lee, PhD、National Taiwan Unerversity Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 201805058DIPA
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.