Clinical Research Directory

Assessment of Residual Congestion in Acute Decompensated Heart Failure

Sponsor: Aarhus University Hospital

Summary

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 ENDPOINT: The primary endpoint is a composite of heart failure readmission and all-cause mortality (time-to-event analysis) after a 90-day period (chart review). 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. The primary analysis will evaluate the association between discharge VExUS and LUS findings and the risk of 90-day heart failure readmission and all-cause mortality using Cox proportional hazards regression. Models will be adjusted for age, sex, and comorbidities. SECONDARY ENDPOINTS: 1. DAOH within 90 days and one year after discharge 2. All-cause mortality within 90 days and one year after discharge 3. Rehospitalization for ADHF within 90 days and one year after discharge 4. Association between discharge VExUS and markers of congestion, including objective markers (jugular venous pressure, peripheral edema, pulmonary rales, and weight change), NT-proBNP, renal function, and echocardiographic measures of cardiac function. 5. Incremental prognostic value of discharge VExUS and LUS beyond standard clinical assessment of congestion (jugular venous pressure, peripheral edema, pulmonary rales, and weight change) for predicting 90-day and one-year heart-failure readmission and all-cause mortality. 6. 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 days. Secondary analyses will employ Cox models for time-to-event outcomes (readmission, mortality, diuretic intensification) and linear regression for continuous outcomes (DAOH, change in diuretic dose). The relationship between discharge VExUS/LUS and post-discharge diuretic use will be evaluated both continuously (dose change) and categorically (intensification vs. no intensification). Incremental prognostic value beyond clinical and biochemical markers (e.g., NT-proBNP) will be assessed using nested model comparisons (likelihood ratio tests, AIC, C-index, NRI, IDI). 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

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