Assessment of Residual Congestion in Acute Decompensated Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy
Moribund
Solitary kidney
Inability to provide written consent
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
580 Participants
are grouped into 1 trial groupGroup A: Patients admitted for acute decompensated heart failure
Trial outcomes
Primary outcomes
1
Composite of heart failure readmission and all-cause mortality
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.
Time frame
90 daysSecondary outcomes
1
Days alive and out of hospital
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.
Time frame
Within 90 days and one year after discharge2
Individual components of the primary endpoint
Time frame
90 days and one year after discharge3
Association between discharge VExUS and markers of congestion
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.
Time frame
At discharge4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aarhus University Hospital
Lead sponsor
Zealand University Hospital
Collaborator
Amager Hospital
Collaborator
Source ClinicalTrials.gov