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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kristoffer Berg-Hansen, MD, PhD
- Número de teléfono: +4560540700
- Correo electrónico: krisbe@rm.dk
Ubicaciones de estudio
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Aarhus, Dinamarca, 8200
- Reclutamiento
- Aarhus University Hospital - Department of Cardiology
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Contacto:
- Kristoffer Berg-Hansen, MD, PhD
- Número de teléfono: +456054070
- Correo electrónico: krisbe@rm.dk
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Copenhagen, Dinamarca, 2650
- Aún no reclutando
- Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology
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Contacto:
- Johannes Grand, MD, PhD
- Correo electrónico: johannes.grand@regionh.dk
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Roskilde, Dinamarca, 400
- Aún no reclutando
- Zealand University Hospital - Department of Cardiology
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Contacto:
- Martin Frydland, MD, PhD
- Correo electrónico: mafry@regionsjaelland.dk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients admitted for acute decompensated heart failure
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite of heart failure readmission and all-cause mortality
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Days alive and out of hospital
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 90 days and 1 year
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90 days and 1 year
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Post-discharge diuretic use
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1-10-72-199-25
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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