Early Care After Discharge of HF Patients (ECAD-HF)
Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.
After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome.
This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.
調査の概要
状態
条件
詳細な説明
At discharge, high-risk HF patients are selected and randomized in two groups:
- Control group: usual disease management according to guidelines and including first medical consultation and biological test within the 4-week time following discharge.
- Active group: consultations with HF specialist including biological test at weeks 1, 2 and 4 are planned in addition to usual management.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Paris、フランス、75010
- Service de Cardiologie - Hôpital Lariboisière
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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
説明
Inclusion Criteria:
- 18 years or more
- consent signed
Acute or decompensated heart failure with one or more of following criteria::
- Discharge BNP > 350 pg/ml or NTproBNP > 2200 pg/ml
- Discharge serum creatinine ≥ 180µM
- Discharge systolic blood pressure ≤ 110mmHg
- Previous hospitalisation for acute heart failure < 6 months
Exclusion Criteria:
- acute coronary syndrome,
- acute myocarditis,
- isolated right HF,
- transient HF,
- planned cardiac surgery,
- high risk of short-term non-cardiac death,
- planned management within rehabilitation center/HF clinic at discharge
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:intensive disease management
Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
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Optimization of treatments Education on the signs of alert of the disease and on the medicines Reduction of the rate of BNP or NTproBNP = 30 % between the exit of the hospitalization and the second consultation Planning of an adapted coverage
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アクティブコンパレータ:usual disease management
usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.
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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 |
時間枠 |
---|---|
Number of participants with all cause death or unplanned hospitalization at 6 months
時間枠:6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
All cause mortality at 12 months
時間枠:one year
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one year
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Unplanned HF-related hospitalization at 6 and 12 months
時間枠:6 and 12 months
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6 and 12 months
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Number of alive and hospitalization-free days at 6 and 12 months
時間枠:6 and 12 months
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6 and 12 months
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Mean and distribution modified Goldman classe at 6 months
時間枠:6 months
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6 months
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Natriuretic peptides blood levels at 6 months.
時間枠:6 months.
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6 months.
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Global cost of patient management
時間枠:from day0 to 12 months
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from day0 to 12 months
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HF-treatment at 6 months
時間枠:6 months
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6 months
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Mean and distribution NYHA classe at 6 months
時間枠:6 months
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6 months
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Analysis of subgroups (LVEF altered or not, first HF episode or not, age> or ≤ 75, Changes in levels of BNP or NT-proBNP between day0 and the second consultation in the active group: ≥ 30% decrease, ≥ 30% increase, Intermediate variation).
時間枠:6 months
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6 months
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Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months
時間枠:6 months
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6 months
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協力者と研究者
捜査官
- 主任研究者:LOGEART Damien, MD, PhD、Lariboisière Hospital, APHP
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
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
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。
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)