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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Taipei, Taiwan, 10002
- Werving
- National Taiwan University Hospital
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Contact:
- Chii-Ming Lee
- Telefoonnummer: 0972-651-087
- E-mail: chiiminglee@ntu.edu.tw
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Enhanced External Counterpulsation
Subjects of Heart failure with 'Enhanced External Counterpulsation" therapy
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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.
Andere namen:
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Geen tussenkomst: No 'Enhanced External Counterpulsation"
Subjects of Heart failure without 'Enhanced External Counterpulsation" therapy
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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the natriuretic peptide (NT-pro-BNP) level will be reduced.
Tijdsspanne: 7 week
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the natriuretic peptide (NT-pro-BNP) level will be reduced
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7 week
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Weaning from intravenous infusion of positive inotropic agent
Tijdsspanne: 24 week
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Weaning from intravenous infusion of positive inotropic agent
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24 week
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Decrease the length of hospital stay.
Tijdsspanne: 24 week
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Decrease the length of hospital stay.
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24 week
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Chii-Ming Lee, PhD, National Taiwan Unerversity Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 201805058DIPA
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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