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Assessment of Residual Congestion in Acute Decompensated Heart Failure (VExUS-AHF)

2 juli 2026 uppdaterad av: Aarhus University Hospital

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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

580

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Kristoffer Berg-Hansen, MD, PhD
Telefonnummer: +4560540700
E-post: krisbe@rm.dk

Studieorter

Danmark
- - Aarhus, Danmark, 8200
    - Rekrytering
    - Aarhus University Hospital - Department of Cardiology
    - Kontakt:
      
      Kristoffer Berg-Hansen, MD, PhD
      
      Telefonnummer: +456054070
      
      E-post: krisbe@rm.dk
  - Copenhagen, Danmark, 2650
    - Har inte rekryterat ännu
    - Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology
    - Kontakt:
      
      Johannes Grand, MD, PhD
      
      E-post: johannes.grand@regionh.dk
  - Roskilde, Danmark, 400
    - Har inte rekryterat ännu
    - Zealand University Hospital - Department of Cardiology
    - Kontakt:
      
      Martin Frydland, MD, PhD
      
      E-post: mafry@regionsjaelland.dk

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Patients admitted for acute decompensated heart failure

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Composite of heart failure readmission and all-cause mortality Tidsram: 90 days	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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Days alive and out of hospital Tidsram: Within 90 days and one year after discharge	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.	Within 90 days and one year after discharge
Individual components of the primary endpoint Tidsram: 90 days and one year after discharge		90 days and one year after discharge
Association between discharge VExUS and markers of congestion Tidsram: At discharge	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.	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 Tidsram: 90 days and 1 year		90 days and 1 year
Post-discharge diuretic use Tidsram: 90 days	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	90 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Aarhus University Hospital

Samarbetspartners

Zealand University Hospital

Amager Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 februari 2026

Primärt slutförande (Beräknad)

1 juni 2028

Avslutad studie (Beräknad)

1 november 2028

Studieregistreringsdatum

Först inskickad

26 juni 2026

Först inskickad som uppfyllde QC-kriterierna