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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Maurizio Eugenio Landolina
- メール:clinical-estimate@isis.it
研究場所
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Pavia、イタリア、27100
- Policlinico San Matteo
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主任研究者:
- Maurizio Eugenio Landolina
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of planned and unplanned admissions
時間枠: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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二次結果の測定
結果測定 |
時間枠 |
---|---|
The number of all cardiac or device related ED visits
時間枠:16 months
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16 months
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The number of all unplanned cardiac or device related clinic/urgent visits
時間枠:16 months
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16 months
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協力者と研究者
捜査官
- 主任研究者:Maurizio Eugenio Landolina、Policlinico San Matteo
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20130004180 del 24/09/2013
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
うっ血性心不全の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)