Status:
UNKNOWN
A Study to Evaluate the Effects of EECP in Patients With Heart Failure
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The aims of this proposal are to investigate whether external enhanced counterpulsation (EECP) can facilitate heart failure (HF) patient weaning from intravenous infusion of positive inotropic agent, ...
Detailed Description
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. Medicati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03857022
Start Date
November 22 2018
End Date
November 30 2020
Last Update
February 27 2019
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 10002