Assessment of Residual Congestion in Acute Decompensated Heart Failure

Aarhus University Hospital580 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

580

Conditions

Acute Heart Failure (AHF)Decompensated Chronic Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults (≥18 years) admitted with ADHF. 2. 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. 3. Treatment with ≥40 mg i.v. furosemide or equivalent dose loop diuretic during admission. Exclusion Criteria: 1. Pregnancy 2. Moribund 3. Solitary kidney 4. Inability to provide written consent

Locations (3)

Aarhus University Hospital - Department of Cardiology

Aarhus, Denmark

RECRUITING

Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology

Copenhagen, Denmark

NOT_YET_RECRUITING

Zealand University Hospital - Department of Cardiology

Roskilde, Denmark

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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 days

Secondary Outcomes

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 discharge

Individual components of the primary endpoint

Time frame: 90 days and one year after discharge

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 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

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