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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Kristoffer Berg-Hansen, MD, PhD
- 전화번호: +4560540700
- 이메일: krisbe@rm.dk
연구 장소
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Aarhus, 덴마크, 8200
- 모병
- Aarhus University Hospital - Department of Cardiology
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연락하다:
- Kristoffer Berg-Hansen, MD, PhD
- 전화번호: +456054070
- 이메일: krisbe@rm.dk
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Copenhagen, 덴마크, 2650
- 아직 모집하지 않음
- Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology
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연락하다:
- Johannes Grand, MD, PhD
- 이메일: johannes.grand@regionh.dk
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Roskilde, 덴마크, 400
- 아직 모집하지 않음
- Zealand University Hospital - Department of Cardiology
-
연락하다:
- Martin Frydland, MD, PhD
- 이메일: mafry@regionsjaelland.dk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Patients admitted for acute decompensated heart failure
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite of heart failure readmission and all-cause mortality
기간: 90 days
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Days alive and out of hospital
기간: Within 90 days and one year after discharge
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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.
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Within 90 days and one year after discharge
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Individual components of the primary endpoint
기간: 90 days and one year after discharge
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90 days and one year after discharge
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Association between discharge VExUS and markers of congestion
기간: At discharge
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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.
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At discharge
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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
기간: 90 days and 1 year
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90 days and 1 year
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Post-discharge diuretic use
기간: 90 days
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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
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90 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
- 1-10-72-199-25
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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