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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei, 대만, 10002
- 모병
- National Taiwan University Hospital
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연락하다:
- Chii-Ming Lee
- 전화번호: 0972-651-087
- 이메일: chiiminglee@ntu.edu.tw
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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간섭 없음: No 'Enhanced External Counterpulsation"
Subjects of Heart failure without 'Enhanced External Counterpulsation" therapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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the natriuretic peptide (NT-pro-BNP) level will be reduced.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Weaning from intravenous infusion of positive inotropic agent
기간: 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.
기간: 24 week
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Decrease the length of hospital stay.
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24 week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chii-Ming Lee, PhD, National Taiwan Unerversity Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 201805058DIPA
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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