Assessment of Residual Congestion in Acute Decompensated Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Heart Failure (AHF), Decompensated Chronic Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Composite of heart failure readmission and all-cause mortality [Time frame: 90 days]
Secondary outcome measures (5)
- Days alive and out of hospital [Time frame: Within 90 days and one year after discharge]
- Individual components of the primary endpoint [Time frame: 90 days and one year after discharge]
- Association between discharge VExUS and markers of congestion [Time frame: 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 [Time frame: 90 days and 1 year]
- Post-discharge diuretic use [Time frame: 90 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 3 centers
- Aarhus University Hospital - Department of Cardiology — Aarhus
- Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology — Copenhagen
- Zealand University Hospital - Department of Cardiology — Roskilde
Identifiers
NCT: NCT07682298 · 1-10-72-199-25