Heart Failure Clinical Trial
Official title:
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
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, and thus decrease the length of hospital stay. The major adverse cardiovascular event (MACE) rate, including death and hospitalization for heart failure, will be monitored for 6 months if patients can be released from hospital. Exercise tolerance (6-minute walking distance) and plasma brain natriuretic peptide (BNP) level will be checked at the end of 6th month.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion criteria All answers must be "Yes" for study entry. 1. Male or female patients between 21-80 years of age. 2. 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. 1. Patients who had MI or coronary artery bypass grafting (CABG) within three months prior to the initiation of EECP treatment. 2. Patients who had transcatheter intervention (PCI) within 2 weeks prior to the initiation of EECP treatment. 3. Significant valvular heart disease, acute myocarditis. 4. Uncontrolled hypertension (blood pressure 180/100 mmHg). 5. Permanent pacemakers or implantable cardioverter defibrillators. 6. Non bypassed left main coronary with a luminal stenosis greater than 50%. 7. Severe symptomatic peripheral vascular disease. 8. History of deep vein thrombosis. 9. Phlebitis or stasis ulcer. 10. Bleeding diathesis, warfarin use with International Normalized Ratio 2.0. 11. Arial fibrillation or frequent ventricular premature beats that interferes with enhanced external counterpulsation triggering. 12. Baseline ECG abnormalities that would interfere with interpretation of exercise ECG. 13. Pregnant women, or women of childbearing potential but not using adequate birth control. 14. 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the natriuretic peptide (NT-pro-BNP) level will be reduced. | the natriuretic peptide (NT-pro-BNP) level will be reduced | 7 week | |
Secondary | Weaning from intravenous infusion of positive inotropic agent | Weaning from intravenous infusion of positive inotropic agent | 24 week | |
Secondary | Decrease the length of hospital stay. | Decrease the length of hospital stay. | 24 week |
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