- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02147340
External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators (ESTIMATE-HF)
External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators: the ESTIMATE-HF Study
연구 개요
상태
정황
상세 설명
Based on positive outcomes from numerous randomized, controlled trials, the current European Society of Cardiology (ESC) guidelines and current American guidelines for the management of chronic heart failure include the implantable defibrillators as a standard of care in selected chronic heart failure patients .
Heart failure patients with implantable defibrillators often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. Device manufacturers offer a technology for remote defibrillator monitoring with the purpose of allowing physicians to remotely access patients' data and reducing unnecessary routine and interim visits. The Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study was a multicenter randomized trial designed to assess whether remote management can reduce emergency healthcare use in heart failure patients implanted with defibrillators endowed with specific diagnostic features compared with standard management consisting of scheduled in-office visits and patient response to audible alerts. Over 16 months, the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or device-related events decreased by 35% and total healthcare visits were 21% less frequent with remote monitoring.
The study confirmed that remote management of heart failure patients implanted with defibrillators allows timely notification of potentially critical situations. Moreover, it has the effect of shifting healthcare visits from the emergency department to the clinic and increasing the appropriateness of in-office visits, thereby reducing costs and the burden on the healthcare system.
Nonetheless, in the EVOLVO study these findings were obtained with defibrillators equipped with specific diagnostic and alerting capabilities, and thus they cannot be fully extended to different technologies. In particular, defibrillators were equipped with these alert capability for the detection of possible fluid accumulation and decompensation, and these alerts accounted for the majority of endpoints recorded during the study.
That alert was shown to be associated with a relatively high rate of false positive detections , and the Diagnostic Outcome Trial in Heart Failure (DOT-HF) recently showed an increased number of hospital admissions among patients with the audible alert enabled.
Alternative systems of RPM (Remote Patient Management) allow recording of the body weight and blood pressure for the management of heart failure. Continuous monitoring of these variables is a fundamental element of the programs of patient monitoring and patient education recommended by the guidelines for the treatment of heart failure.
Although the daily measure of body weight and pressure is present in most telemedicine programs described in the literature , , clinical evidence obtained specifically in the population of patients referred to the implantable defibrillator therapy is scarce. The large observational study ALTITUDE has suggested the possibility of a better prognosis of patients managed via RPM, in particular if provided with sensors for the measurement of weight and pressure.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Pavia, 이탈리아, 27100
- Policlinico San Matteo
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patient with left ventricular systolic dysfunction, left ventricular ejection fraction ≤ 35%, as documented at the moment of device implant.
- Patient implanted with a Cardiac Resynchronization Therapy-Defibrillator (CRT-D) or implantable defibrillator (ICD) device.
- Patient must be able and willing to replace regularly-scheduled in-office routine follow-ups with remote follow-ups.
- Patient must be able to attend all required follow-up visits at the study center.
Exclusion Criteria:
- Patient is less than 18 years of age.
- Patient is unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
- Patient life expectancy is less than 12 months.
- Patient is participating in another clinical study that may have an impact on the study endpoints.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Heart failure patients with ICD
Heart failure patients with ICD and RPM system equipped with sensors for the measurement of weight and pressure
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of planned and unplanned admissions
기간: 16 months
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All planned and unplanned hospital and Emergency Department (ED) admissions (not involving an overnight stay) All planned and unplanned hospitalizations (involving an overnight stay or resulting in death)
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16 months
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2차 결과 측정
결과 측정 |
기간 |
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The number of all cardiac or device related ED visits
기간: 16 months
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16 months
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The number of all unplanned cardiac or device related clinic/urgent visits
기간: 16 months
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16 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Maurizio Eugenio Landolina, Policlinico San Matteo
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20130004180 del 24/09/2013
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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