Assessment of Residual Congestion in Acute Decompensated Heart Failure (VExUS-AHF)
DESIGN:
A prospective, multicenter, observational cohort study including 580 patients admitted for acute decompensated heart failure (ADHF).
Ultrasound assessment of congestion (VExUS and LUS) will be performed serially during admission: within 48 hours of admission, at the time diuretic therapy is switched from intravenous to oral, and on the day of discharge. The discharge assessment will serve as the primary predictor.
Treating physicians will be blinded to all ultrasound findings. Patients will be followed for 90 days by telephone follow-up and chart review for the primary endpoint, with extended chart review at one year for selected secondary endpoints.
AIMS:
To determine whether combined ultrasound assessment of venous (VExUS) and pulmonary congestion (LUS) at discharge predicts heart failure readmission and all-cause mortality in patients hospitalized with ADHF.
HYPOTHESIS:
Abnormal VExUS and/or LUS findings at discharge are associated with a higher risk of heart failure readmission and all-cause mortality after 90 days.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Kristoffer Berg-Hansen, MD, PhD
- 電話番号：+4560540700
- メール：krisbe@rm.dk
研究場所
-
-
-
Aarhus、デンマーク、8200
- 募集
- Aarhus University Hospital - Department of Cardiology
-
コンタクト：
- Kristoffer Berg-Hansen, MD, PhD
- 電話番号：+456054070
- メール：krisbe@rm.dk
-
Copenhagen、デンマーク、2650
- まだ募集していません
- Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology
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コンタクト：
- Johannes Grand, MD, PhD
- メール：johannes.grand@regionh.dk
-
Roskilde、デンマーク、400
- まだ募集していません
- Zealand University Hospital - Department of Cardiology
-
コンタクト：
- Martin Frydland, MD, PhD
- メール：mafry@regionsjaelland.dk
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
Inclusion criteria Age ≥18 years admitted with ADHF, treated with intravenous loop diuretics (≥40 mg furosemide or an equivalent dose of another loop diuretic) during admission, and able to provide written consent will be eligible for inclusion. Clinical evidence of congestion during admission, indicated by ≥1 of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiologic/ultrasound evidence of pulmonary congestion.
Exclusion criteria Pregnancy, moribund, solitary kidney, or inability to provide written consent
説明
Inclusion Criteria:
- Adults (≥18 years) admitted with ADHF.
- Clinical evidence of congestion during admission, indicated by ≥1 of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiologic/ultrasound evidence of pulmonary congestion.
- Treatment with ≥40 mg i.v. furosemide or equivalent dose loop diuretic during admission.
Exclusion Criteria:
- Pregnancy
- Moribund
- Solitary kidney
- Inability to provide written consent
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 |
|---|
|
Patients admitted for acute decompensated heart failure
|
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 |
|---|---|---|
|
Composite of heart failure readmission and all-cause mortality
時間枠：90 days
|
Time-to-event analysis. Endpoints appointed by a blinded adjudication committee. Abnormal VExUS will be defined according to criteria from our ongoing validation study. Abnormal LUS is defined as ≥3 B-lines in ≥2 scanning zones per hemithorax (8-zone method) or ≥15 total B-lines overall. |
90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Days alive and out of hospital
時間枠：Within 90 days and one year after discharge
|
Days alive and out of any hospital within 90 days and 1 year, indexed to discharge; death counts as 0 days.
Computed over the complete fixed window using chart-based ascertainment of vital status and admissions.
Patients censored early for reasons other than death (e.g.
withdrawal) are handled by censoring or exclusion (not scored 0, since 0 denotes death).
Analyzed with rank-based methods given the zero-spike and skew.
|
Within 90 days and one year after discharge
|
|
Individual components of the primary endpoint
時間枠：90 days and one year after discharge
|
90 days and one year after discharge
|
|
|
Association between discharge VExUS and markers of congestion
時間枠：At discharge
|
Markers of congestion: Objective markers (jugular venous pressure, peripheral edema, pulmonary rales, and weight change), NT-proBNP, renal function, and echocardiographic measures of cardiac function.
|
At discharge
|
|
Incremental prognostic value of discharge VExUS and LUS beyond standard clinical assessment of congestion for predicting 90-day and one-year heart-failure readmission and all-cause mortality
時間枠：90 days and 1 year
|
90 days and 1 year
|
|
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Post-discharge diuretic use
時間枠：90 days
|
Defined as the change in loop diuretic dose (furosemide-equivalent) from discharge to 30- and 90-day follow-up, and occurrence of diuretic intensification (dose increase or addition of thiazide-type diuretic) within 90 day
|
90 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
その他の研究ID番号
- 1-10-72-199-25
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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